Cataracts Clinical Trials
 Pediatrics Clinical Trials
 Other Ophthalmology Clinical Trials

Clinical Trials
Storm Eye Institute physicians are involved in ongoing clinical trials and studies for the treatment of eye disorders and diseases. Being part of a major medical center allows access to collaborative studies not otherwise possible.

Several studies are being conducted at Storm Eye Institute which may involve evaluation of medications or surgical techniques. Your doctor will recommend which clinical study would be most appropriate for you. As each study has its own advantages and disadvantages, all details will be explained to you prior to your joining a clinical trial. You will also receive a written copy of the consent form with these details.

Benefits
You may or may not receive compensation for participating in a study. However, most study patients enjoy the benefit of participating in a study that allows them to receive some of the latest and most advanced options and surgical techniques. Of course, patients enjoy the added benefit of participating in a trial that will obtain more information about treatment options of the eye and the development of future treatments and medications.

Possible Discomfort & Risk
Side effects and discomforts associated with the study treatment will be dependent upon the treatment and study you participate in. If at any time you experience any changes or discomfort, your doctor will evaluate your eye to determine if you should continue in the study and appropriate therapy will be initiated.

Duration
Each study will have an individual schedule of visits. Some studies will require more frequent visits and some studies will be shorter in duration. The duration will be explained in further detail at the time of your screening. 

The choice of participation is always yours. You may decide to discontinue at any time, even if you have already signed the consent form.

Ask our staff about participation. Your doctor and the Clinical Trials Coordinator will be happy to answer any questions you have.

Below is a list of current clinical trials at Storm Eye Institute. Based upon the results of your eye examination, your doctor will determine your eligibility to participate in a clinical study.

 Clinical Study of the ACRYSOF^® II Natural IQ IOL 

This research study will check the safety and usefulness of an investigational artificial lens, AcrySof II Natural IQ. This lens will be surgically placed in a subject's eye as a replacement for their natural lens when it is surgically removed during cataract surgery.

   To learn more about this trial please call Carol at (843) 792-2338. 

Principal Investigator:  Matthew J. Nutaitis, MD

Patient Inclusion Criteria:

• Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with cataract;
• Calculated lens power is within the available range;
• Willing and able to complete all required postoperative visits;
• Planned cataract removal by phacoemulsification;
• Potential postoperative visual acuity of 0.2 logMAR or better in study eye;
• Preoperative astigmatism of 1.5D or less, measured by keratometry in study eye;
  Note: corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
• Clear intraocular media other than cataract in study eyes;
• Able to comprehend and sign a statement of informed consent;
• Preoperative Best Corrected Distance Visual Acuity  (BCDVA) worse than 0.2 logMAR, if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse that 0.2 logMAR;
• Pupil size greater than or equal to 6 mm after dilation.
• Subject must be willing and able to comply with scheduled visits and other study procedures.

Patient Exclusion Criteria Before Surgery:

• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR;
• Previous corneal refractive surgery;  
• Amblyopia;
• Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
• Diabetic retinopathy;
• Extremely shallow anterior chamber not due to swollen cataract;
• Microphthalmos;
• Previous retinal detachment
• Previous corneal transplant
• Recurrent severe anterior or posterior segment inflammation of unknown etiology;
• Rubella or traumatic cataract
• Iris neovascularization
• Uncontrolled glaucoma
• Aniridia
• Optic nerve atrophy
• Pregnancy
• Any subject currently participating in another investigational drug or device study that may confound the results of this investigation;
• Current or previous usage of alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g. Flomax (tamsulosin HCL), Hyrtrin or Cardura);
• Diagnosis of pseudoexfoliation syndrome.

Surgical Exclusion Criteria:

• Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions;
• Mechanical or surgical manipulation required to enlarge the pupil;
• Significant vitreous loss;
• Significant anterior chamber hyphema;
• Uncontrollable intraocular pressure;
• Zonular or capsular rupture
• Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.

Cost to subject: Insurance filed for surgical procedure

Subject Compensation: Subjects will be provided a payment of fifty dollars ($50.00) for the completion of Visit 3 (30-60 days after surgery), Visit 4 (120-180 days after surgery) and Visit 5 (330-420 days after surgery), for a total payment of one hundred and fifty dollars ($150.00). This payment is meant to compensate subjects for their time and travel costs.

Recruitment: Ongoing

Contact: Carol Bradham, (843) 792-2338 

 A Clinical Safety and Efficacy Comparison of Nevanac^® 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients

This study is designed to show whether NEVANAC^® 0.1% is superior to Nepafenac ophthalmic suspension vehicle (placebo).  NEVANAC^® is a topical ocular drug indicated for the treatment of pain and inflammation associated with cataract surgery. 

Main Inclusion Criteria:

• Patients must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens in the lens capsule
• History of Type 1 or Type 2 diabetes
• NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale
• Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB)

Main Exclusion Criteria:

• Central subfiled macular thickness > 250 um in the study eye prior to cataract surgery as determined by OCT per reading center or investigator
• Presence of CME or cystoid abnormalities in the study eye as detected by OCT or fundus exam per reading center or investigator
• Presence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam (based on ETDRS criteria) per investigator
• Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by OCT or fundus exam per reading center or investigator
• History of retinal detachment or macular surgeries (e.g., macular hole, epiretinal membrane removal, etc) in the study eye
• Prior focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted)
• Prior panretinal photocoagulation in the study eye
• Prior history of ischemic maculopathy (as confirmed by fluorescein angiography) in the study eye
• History of central retinal vein occlusion (CRVO) branch retinal vein occlusion (BRVO), central retinal artery occlusion (CRAO), or branch retinal artery occlusion (BRAO) in the study eye
• History of exudative age-related macular degeneration (wet ARMD) or geographic atrophy in the study eye (Note: dry ARMD is permitted)
• Patients planning to have cataract surgery in their fellow, non-study eye prior to the Day 90 postoperative study visit
• Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculoplasty, corneal transplant). Note: A planned relaxing keratotomy may be performed for the correction of astigmatism (this will not require exclusion from the per protocol data set)
• Lens pseudoexfoliation syndrome or zonular compromise in the study eye
• Patients who have received corneal transplants in the study eye
• Patients with orbitopathy of Graves' disease in either eye
• Patients with neurotrophic keratopathy
• History of Keratoconjuntivitis sicca (dry eye syndrome)
• Patients whose baseline cumulative corneal fluorscein staining score (i.e., sum of scores for all 5 corneal regions) for the study eye is graded as >5 or whose baseline corneal fluorescein staining score in any single region for the study eye (including traumatic cataract)
• History of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, uveitis, iridocyclitis) in the study eye
• Congenital ocular anomaly (e.g., aniridia, congenital cataract)
• Any iris abnormality in the study eye (e.g., iris atrophy or rubeosis iridis)
• Presence of considerable media or lens opacity precluding fundus exam or adequate baseline OCT for the study eye
• Patients with a visually nonfunctional fellow eye, defined as a best-corrected visual acuity of 20/20 Snellen or worse (<35 ETDRS letters).  Note: A visual acuity that is reduced by a cataract is allowed in a Potential Acuity Meter (or similar instrument) demonstrates a potential acuity of 20/60 Snellen or better > 61 ETDRS letters).
• Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia)
• Patients who are receiving dialysis
• Patients, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs.  Increased risk may be associated with a history of corneal problems; previous surgery or trauma to the affected eye; surgical complications; complicated ocular surgeries or repeat ocular surgeries within a short period of time; corneal epithelial defects; lid disorders or surgeries; connective tissue disorders (including rheumatoid arthritis, Sjorgren's syndrome, systemic lupus erythematosus, temporal arteritis, polymyalgia); anterior basement membrane disease; chronic inflammation; atopic disease; systemic NSAID use; or systemic steroid use.

Exclusions related to systemic or ocular medications:

• Use of medications with known or suspected retinal toxicity, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine (Mellaril), chloropromazine (thorizine)
• Use of supplemental niacin >3 grams/day (associated with cystoid macular edema)
• Use of daily doses of topical ocular NSAIDs (Voltaren, Acular LS, etc.), in the study eye within 7 days prior to surgery
• Use of daily doses of systemic NSAIDs (ibuprofen, naproxen, etc.) within 7 days prior to surgery (through study exit), with the exception of low-dose (81 mg) aspirin
• Use of systemic steroids within 14 days prior to surgery (through study exit)
• Use of daily doses of topical ocular NSAIDs (Voltaren, Acular LS, etc.) in the non-study eye through study exit (Note: All topical ocular NSAIDs must be discontinued 1 day prior to surgery)
• Use of daily doses of topical ocular steroids in the non-study eye through study exit (Note:All topical ocular steroids must be discontinued 1 day prior to surgery
• Treatment with intraocular steroids, in the study eye, within 14 days prior to surgery
• Use of topical ocular steroids, in the study eye, within 14 days prior to surgery
• Treatment with intraocular or periocular steroids in the study eye within 6 months prior to surgery
• Known or suspected allergy or hypersensitivity to a nonsteroidal anti-inflammatory drug (NSAID), corticosteroids, or to any component of the study medication
• Patients with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for those patients will be left to the judgment of the physician
• Patients using a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN, etc). Patients must discontinue use beginning 4 days prior to surgery until study exit

Other Exclusions:

• The Alcon Medical Monitor may declare any patient ineligible for a valid medical reason.
• Implantation of an investigational or multifocal IOL in the study eye
• Participation in any other clinical study within 30 days of the Baseline examination
• The fellow eye of an individual currently or previously enrolled in the study (each patient will have only one eye enrolled in the study)
• Females of childbearing potential (those who are not surgically sterilized or post-menopausal) may not participate in this study if any of the following conditions exist:
• a.  they are breastfeeding;
• b.  they have a positive urine pregnancy test at screening;
• c.  they are not willing to undergo a urine pregnancy test upon entering or exiting the study;
• d.  they intend to become pregnant during the study; or,
• e.  they do not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal - oral, implantable, transdermal, or injectable contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; IUD; or, surgical sterilization of partner)

Cost to subject: Yes (insurance coverage)

Subject Compensation:  Subjects will be paid $40.00 per visit up to $360.00 for those study visits (Screening/Baseline, Surgery Day, Day 1, Day 7, Day 14, Day 30, Day 60, and Day 90) which may not be typically performed by your study doctor for normal cataract surgery follow-up.  If you do not complete all the study visits, you will be paid a pro-rated amount.  Payment will be made upon completion of your participation in the study.

Contact: Carol Bradham, (843) 792-2338 

 Device Evaluation Study to Assess the Physical and Clinical Performance of Prototype Punctal Plug Design Iterations

 To learn more about this trial please call Carol at (843) 792-2338. 

Principal Investigator: Robery Black, OD

Main Inclusion Criteria:

• Subjects who are healthy men or women 50 years of age or older (exception: subjects younger than 50 years who are already participating in the study may be re-enrolled).
• Subjects who sign an approved informed consent form for the study.
• Subjects who are willing to comply with the protocol and study visit schedule.

Main Exclusion Criteria:

• Subjects with a history of, or active, lid disease (i.e., blepharitis, meibonianitis) or structural lid abnormalities (i.e., ectropion, entropion). A history of mild, uncomplicated blepharitis is not excluded.
• Subjects currently on any ocular topical medications.
• Subjects with a known sensitivity to silicone or other components of the investigational punctum plug.
• Subjects who, in the Investigator's opinion, have any severe acute or chronic medical condition that may increase the risk associated with study participation or administration of the study device, or interfere with the interpretation of study results.
• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within the last 4 weeks. Subjects who have previously participated in this study may be re-enrolled with no delay.

Subject Compensation:

Recruitment: Ongoing

Contact: Carol Bradham, (843) 792-2338 

  Infant Aphakia Treatment Study  

A small number of infants are born with a cataract in their eye. The standard treatment is to remove the cataract and place a contact lens on the eye along with patching of the non cataract eye to force the eye to focus and develop naturally. This can be difficult and stressful for both the parents and the child. An adult who undergoes cataract surgery has an intraocular lens (IOL) implanted to correct vision. This study will evaluate the effectiveness of implanting intraocular lenses in infants who have their cataracts removed.

 To learn more about this trial please call Margaret Bozic at (843) 792-2095 

Purpose: To compare the results of treatment for infant cataract using intraocular lens implantation after phacoemulsification and the use of glasses or contact lenses. 

Principal Investigator:  M. Edward Wilson, MD

Main Inclusion Criteria:

• Visually significant congenital cataract in only one eye
• Age 28 days to <7 months and at least 41 post-conceptional weeks at the time of cataract surgery

Main Exclusion Criteria:

• Microcornea (diameter <9mm)
• Glaucoma, uveitis, retinal or optic nerve disease
• Prematurity
• Anterior persistent fetal vasculature (PFV) causing stretching of the ciliary processes or posterior PFV
• Ocular disease in the fellow eye

Cost to subject:  Yes (insurance coverage)

Subject Compensation: Yes - $100 quarterly and an additional $100 per year

Recruitment: Ongoing

Contact: Margaret Bozic, (843) 792-2095

 AMBLYOPIA TREATMENT STUDY (ATS13) An Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old

This study is being conducted to see if wearing glasses to treat amblyopia (lazy eye) caused by crossing of the eyes helps improve the amblyopia or not.

 To learn more about this trial please call Carol at (843) 792-2338

Principal Investigator:  Ronald GW Teed, MD

Main Inclusion& Exclusion Criteria:

• Age 3- < 7 years
• Able to perform visual acuity testing using the ATS single-surround HOTV protocol
  Ambloypia associated with strabismus (comitant or incomitant) with our without anisometropia
• At least one of the following criteria must be met:
  a. Heterotropia at distance and/or near fixation on examination (without spectacles)
  b. History of strabismus surgery (or botulinum toxin extraocular muscle injection)
  c. Documented history of strabismus that is no longer present (and which in the judgment of the investigator is the cause of the amblyopia)
• Visual acuity measured in each eye according to the procedures that meet the following criteria:
  a. Amblyopic eye 20/40 to 20/400 inclusive
  b. Sound eye > 20/40
  c. Inter-eye acuity difference > 3 logMAR lines (i.e., amblyopic eye acuity at least 3 logMAR lines worse than sound eye acuity)
• No previous spectacle correction
• Refractive error meeting at least 1 of the following criteria > 1.00D of astigmatism in the amblyopic eye, > 1.00D spherical equivalent anisometropica, or > +2.00D spherical equivalent hyperopia in either eye.
• Investigator wishes to prescribe spectacles to correct refractive error
• No prior amblyopia treatment
• No current vision therapy or orthoptics
• No ocular cause for reduced visual acuity
• Ocular examination within 2 months prior to enrollment
• Cycloplegic refraction within 2 months prior to enrollment
• No myopia (>-0.25D spherical equivalent)
• No prior intraocular or refractive surgery
• No strabismus surgery planned in the 9 weeks following the Baseline Visit
• Parent understand protocol and is willing to accept treatment
• Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff 
• Relocation outside of area of an active ATS site within next 6 months not anticipated 

Cost to subject:  The study will not pay for any of the costs of your child’s medical care.  All of the study visits are considered part of routine patient care.  Therefore, you or your insurance company will be responsible for the payments for the visits. The National Eye Institute will provide funds for services specific to the research study, but will not cover patient services considered to be routine patient care. The glasses given to your child will be paid for by this study.  If it is determined by the study doctor that replacement glasses are required these will be paid for by the study.

Subject Compensation: You will be given $25 per completed exam for the 9-week visit, the 18-week visit, and each additional follow-up study visit after the 18-week visit, up to a maximum of $150.  This payment is meant to cover your time involved in the study and any travel expenses involved with coming to the visits.  Payment for all exams will be made directly to you by the central coordinating center in Tampa, Florida.  Payments will be made for any completed visit in the month following each completed visit.  You will receive payment for completed visits even if your child leaves the study before the end.  If your expenses exceed $25 per visit and you will be unable to complete a visit without additional funds, please discuss this with the study staff.

Contact: Carol Bradham (843) 792-2338

  Nasolacrimal Duct Obstruction Study (NLD3): A Randomized Trial Comparing Immediate Probing in an Office Setting with Deferred Probing in a Facility Setting for Treatment of Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old

 To learn more about this trial please call Carol at (843) 792-2338

Principal Investigator:  Ronald GW Teed, MD

Main Inclusion Criteria:

• Age 6 to < 10 months
• Onset of NLDO symptoms and/or signs prior to 6 months chronological age in study eye(s)
• Presence in study eye (s) of epiphora, increased tear film, and/or mucous discharge in the absence of an upper respiratory infection or an ocular surface irritation that investigator believes is due to NLDO
• At least one open punctum present in study eye(s) A history of NLDO treatment with lacrimal massage, topical antibiotics or steroids, or systemic antibiotics is permitted

Exclusion Criteria:

• History of nasolacrimal duct surgery including probing, nasolacrimal intubation, balloon catheter dilations, or dacryocystorhinostromy in study eye()\
• History of trauma to the lacrimal drainage system of the study eye(s)
• Glaucoma in study eye(s)
• Corneal surface disease in study eye(s)
• Microphthalmia in study eye(s)
• Down Syndrome
• Craniosynostosis
• Goldenhar sequence
• Clefting syndromes
• Hemifacial microsomia
• Midline facial anomalies

Cost to subject: The National Eye Institute will provide funds for services specific to the research study, but will not cover patient services considered to be routine patient care.

• The study will pay for the follow-up visits 26-weeks after enrollment and at 18 months of age.
• Eye drops that are prescribed will be provided at no cost by the study.
• The probing procedure, any additional procedure that is needed, and any additional follow up visits will be your or your insurance company's responsibility.
• Note that the costs of the probing procedures are not the same.  Deferred probing done in a hospital or surgery center usually costs more than an immediate probing done in the office.  However, it is expected that many children assigned to the deferred facility probing group will have the condition resolve and will not need a probing procedure at all.

Subject Compensation: Subjects will receive $30 for completion of the 26-week visit and $30 for completion of the visit at age 18 months.  These payments are meant to cover your time involved in the study and any travel expenses involved with coming to the visits.  Payment will be made directly to you by the central coordinating center in Tampa, Florida in the month following each completed visit.  If your expenses exceed $30 per visit and you will be unable to complete a visit without additional funds, please discuss this with the study staff.

Recruitment: Ongoing

Contact: Carol Bradham (843) 792-2338

To compare the immersion A-scan biometry measurements to that of applanation A-scan biometry measurements of pediatric patients with cataract, or who have undergone cataract sur

To learn more about this trial please call Rupal Trivedi (843) 792-6301

Principal Investigator: Rupal H. Trivedi 

Main Inclusion Criteria:

• The Study population of 50 subjects will include all patients undergoing AL measurement
  of an eye at the Pediatric Eye Clinic of Storm Eye Institute (ages: birth to 25 years-of-age). 

• Cost to subject: You will not be charged for any of the study procedures.

• Subject Compensation: There is no patient compensation for participating in ths study

Recruitment: Ongoing

Contact: Rupal Trivedi (843) 792-6301

 A NON-TREATMENT STUDY OF RISK FACTORS FOR NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION)

 To learn more about this trial please call Margaret at (843) 792-2095

Principal Investigator: Pamela S. Chavis, MD 

Main Inclusion Criteria:

• Male aged >45 years;
• Experienced abrupt visual change;
• Experienced monocular symptoms;
• Presented to an ophthalmologist within 3 weeks of symptom onset;
• Personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Pain consistent with an arteritic/inflammatory process or optic neuritis;
• History of NAION or optic neuritis;
• Daily use of PDE5 inhibitors for pulmonary arterial hypertension;
• Inability to complete the subject interview for any reason;
• Any medical or psychological condition/disorder that would compromise the subject's ability to provide written informed consent and/or comply with study procedures;
• Participation in other studies within 60 days prior to entry in the study.

Cost to subject: Pfizer will cover the cost of the fundus photograph; however, other treatments and procedures that are part of standard of care will not be covered.  If you have health insurance, the cost of these standard of care services may be billed to your insurance company.  Your health insurance may cover these costs.  If it does not, the costs will be your responsibility.  If you do not have health insurance, the cost of these standard of care services will be billed to you. You may need to receive medical care that is not listed in this document.  Pfizer will not cover the costs of that care unless it is needed to treat a research injury.

Subject Compensation: By participating in this research study, it is anticipated that your visit will last approximately one (1) hour longer than if you were not participating in this study.   By participating in this research study, you may be randomly selected for the telephone interview, the fundus photography, and/or the blood draw.  

If you are selected for any of these additional procedures, the compensation for your time will be Fifty US Dollars (US $50).  If you are not randomly selected for these additional procedures, your compensation will be Twenty-Five US Dollars (US $25).  Your payment will be available to you upon completion of these procedures.

Recruitment: Ongoing

Contact: Margaret Bozic (843) 792-2095

 Diabetic Retinopathy and Sickle Cell Trait

The objective of this research study is to evaluate the relationship between sickle cell trait and the progression of diabetic retinopathy.  

 To learn more about this trial please call Margaret at (843) 792-2095 or Carol at (843) 792-2338

Principal Investigator: Esther M. Bowie, MD 

Main Inclusion Criteria:

• Self-identified African-American patients with diabetes will be identified from Dr Bowie's retina clinic at Storm Eye Institute. These subjects are either being screened or treated for the progression of diabetic retinopathy.

Cost to subject: You will not be charged for any of the study treatments or procedures. 

Subject Compensation: There is no financial compensation for your participation in this study.  

Recruitment: Ongoing

Contact: Margaret Bozic (843) 792-2095 or Carol Bradham at (843) 792-2338