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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.
 A Masked Comparison of Acular LS plus Steroid versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients
The purpose of this study is to determine if the use of Acular LS, a non-steroidal anti-inflammatory drug in combination with a steroid (Pred Forte) will reduce the occurrence of CME (Cystoid Macula Edema) in comparison to using the steroid alone.
 To learn more about this trial please call Carol at (843) 792-2338.
Principal Investigator: Kerry Solomon, MD Treatments/Procedures: Randomization: Yes Main Inclusion Criteria: - Age 18 or greater scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA post-operatively
- Must be in general good health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (i.e. diabetics with normal retinal exams)
- Ability to provide informed consent and likely to complete all study visits
Main Exclusion Criteria: - Known contraindication to any study medication or any of their components
- Uncontrolled systemic disease
- Required use of ocular medications other than the study medications during the study
- Abnormal preoperative OCTs if obtainable
- Diabetic patients with a history of macular edema or diabetic retinopathy
- AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
Cost to subject: Insurance filed for surgical procedure Subject Compensation: Yes - $100 Recruitment: Ongoing
Contact: Carol Bradham, (843) 792-2338 Multifocal Intraocular Lens (IOL) for use in cataract surgery
Patients with cataracts that affect their vision and quality of life must have their natural lens removed and replaced with an artificial lens. Until recently all artificial lenses corrected only distance vision. In other words, you still needed to wear reading glasses after your cataracts were removed. The purpose of this study is to evaluate the safety and effectiveness of an experimental artificial lens that will correct both your distance and your near vision.
To learn more about this trial please call Carol at (843) 792-2338. Purpose: To evaluate the safety and effectiveness of an experimental multifocal intraocular lens for use in bilateral cataract surgery. Principal Investigator: Kerry Solomon, MD Treatments/Procedures: Phacoemulsification to remove cataract Randomization: No Main Inclusion Criteria: - Age 18 or greater; bilateral cataracts for which phacoemulsification extraction and posterior intraocular lens (IOL) implantation has been planned for both eyes
- Preoperative BCDVA worse than Snellen 20/40
- Preoperative corneal astigmatism of 1.0 D or less
Main Exclusion Criteria: - Use of systemic or ocular medications that may affect vision
- Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., diabetes mellitus, immunocompromised, connective tissue disease, diabetes, etc.)
- Uncontrolled systemic or ocular disease (e.g., uncontrolled ocular hypertension or glaucomatous changes in the retina)
- Known pathology that may affect visual acuity, particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- Diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
Cost to subject: Yes (insurance coverage) Subject Compensation: Yes - $500 Recruitment: Ongoing
Contact: Carol Bradham, (843) 792-2338 Evaluation of ReSTOR®Intraocular Lens (IOL)
Until recently all artificial lenses implanted after the removal of cataracts corrected only distance vision. Reading glasses were still required. Alcon’s new ReSTOR® lens corrects near, intermediate, and distance vision. The purpose of this study is to evaluate the quality of vision with the ReSTOR® lens and determine the percentage of subjects who no longer have to use glasses.
To learn more about this trial please call Carol at (843) 792-2338. Purpose: To evaluate the of an quality of vision with the ReSTOR® lens and determine the percentage of patients who no longer have to use glasses. Principal Investigator: Kerry Solomon, MD Treatments/Procedures: Phacoemulsification to remove cataract Randomization: No Main Inclusion Criteria: - 21 to 70 years of age; bilateral cataracts for which phacoemulsification extraction and posterior intraocular lens (IOL) implantation has been planned for both eyes
- Preoperative astigmatism of 1.0D or less
Main Exclusion Criteria: - Greater than 70 years of age
- Significant corneal aberration
- Retinal conditions or predisposition to retinal conditions
- Previous history or a predisposition to retinal detachment or proliferative diabetic retinopathy
- Amblyopia
- Glaucoma
- Any disease producing an inflammatory reaction in the eye
- Pre-existing ocular condition which may negatively impact the stability of the implant
Cost to subject: Yes (insurance coverage) Subject Compensation: Yes - $200 Recruitment: Ongoing
Contact: Carol Bradham, (843) 792-2338
Intraocular lens for the correction of severe nearsightedness (myopia)
Patients with severe myopia (nearsightedness) must now correct their vision with contact lenses or thick glasses. They are not good candidates for LASIK. The purpose of this study is to gather information on the safety and effectiveness of a new surgically-implanted lens that will correct severe myopia. The lens is implanted in the front portion of the eye.
To learn more about this trial please call Carol at (843) 792-2338.
Purpose: To study the safety and effectiveness of an intraocular lens in the correction of severe myopia. Principal Investigator: Kerry Solomon, MD Treatments/Procedures: Implantation of an intraocular lens Randomization: No Main Inclusion Criteria: - 18-49 years of age
- A diagnosis of stable severe myopia
- Preoperative best spectacle corrected visual acuity of +0.3 logMar or lower
Main Exclusion Criteria: - Clinically significant amblyopia
- Myopia which is still increasing
- Astigmatism greater than 2.00 diopters
- Any type of glaucoma (primary or secondary), ocular hypertension >21mm Hg
- Cataract of any type or degree
- History of macular edema, macular degeneration or history of retinal detachment
Cost to subject: Yes - $750 for surgical costs; the procedure is not covered by insurance Subject Compensation: No Recruitment: Closed Analysis of visual outcomes, contrast sensitivity, glare, induction of high order aberrations and Wavefront technology following LASIK surgery.
Laser Assisted in situ (LASIK) is the most common keratorefractive procedure used worldwide. As technique and instrumentation improve, patients have come to expect painless surgery with immediate results. Postoperative visual acuity and patient satisfaction has a high success rate however, there are still complications and undesirable side effects such as glare, infection and dry eye syndrome. Glare, according to current literature, is not uncommon following LASIK surgery and it can be lifestyle-altering for some patients. The introduction of wavefront analysis has opened a new era in cornea refractive surgery. Wavefront is a non-invasive method which measures sphere, cylinder, axis and high order aberrations of the entire optical system.
To learn more about this trial please call Sandra Brown at (843) 216-2020 Purpose: To evaluate visual outcomes, contrast sensitivity, glare testing and induced high order aberrations induced by different laser technologies and to evaluate differences in aberrometer technology.
Principal Investigator: Kerry Solomon, MD Treatments/Procedures: All patients will undergo either conventional or custom LASIK surgery at their choice. Randomization: Patients in either the conventional or custom groups will be randomized between the three refractive lasers available at Magill Laser Center. Main Inclusion Criteria: All patients will be 18 years of age or older undergoing bilateral LASIK surgery with a myopic range of 0 up to -7.00 D with no more than -5.00 D of astigmatism. Main Exclusion Criteria: A history of ocular disease, previous eye surgery, pupils > 8.00mm, thin corneas, irregular astigmatism, or unstable refraction. Cost to subject: Cost of the LASIK procedure. Subject Compensation: Yes. $50.00 if one and three month postoperative visits are completed. Recruitment: Closed Comparison of AmadeusTM Microkeratome to INTRALASE®
LASIK surgery involves cutting a flap in the cornea of the eye so the cornea can be reshaped. The surgeon uses a machine to cut that flap. The purpose of this study is to compare two different machines - one that uses a blade and one that uses a laser.
To learn more about this trial please call Sandra Brown at (843) 216-2020 Purpose: The purpose of this study is to compare accuracy and reproducibility of flap thicknesses and induction of aberrations between the INTRALASE® and the Amadeus™ microkeratome. The induction and/or severity of dry eye syndrome following LASIK will also be evaluated.
Principal Investigator: Kerry Solomon, MD Treatments/Procedures: LASIK surgery using INTRALASE in one eye and Amadeus in the other eye. Randomization: Yes Main Inclusion Criteria: - 18 years of age or greater
- Bilateral myopia
- Good candidate for LASIK surgery
Main Exclusion Criteria: - History of ocular pathologies which would affect tear film production (such as Sjögren´s syndrome)
- Previous ocular surgery
- Thin corneas
- Irregular astigmatism, asymmetric astigmatism and unstable refraction
Cost to subject: Yes - the cost of LASIK surgery is not covered by insurance Subject Compensation: Yes - $50 Recruitment: Ongoing Contact: Sandra Brown, (843) 216-2020
Bacterial conjunctivitis
Bacterial conjunctivitis, or "pink eye", is a common problem, particularly for children. The purpose of this study is to test the safety and effectiveness of a new medication to treat pink eye. This medication may require fewer doses to treat the condition.
To learn more about this trial please call Margaret Bozic at (843) 792-2095.
Purpose: To compare the efficacy and safety of two medications in the treatment of bacterial conjunctivitis. Principal Investigator: M. Millicent Peterseim, MD Treatments/Procedures: 3 visits over a 1 week period; daily treatment with one of the study medicines; patient must keep a diary recording the times of dosing. Randomization: Yes Main Inclusion Criteria: - At least 1 year of age
- Clinical diagnosis of acute bacterial conjunctivitis with mucopurulent or purulent conjunctival discharge and redness in at least one eye
- Symptoms present for 3 days or less
- Best corrected visual acuity equal to or better than 20/100 in both eyes
Main Exclusion Criteria: - Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes or cystic fibrosis)
- Any clinically significant cardiovascular disorders (e.g. unstable angina, myocardial infarction or cerebrovascular accident within the past 6 months, Class III or IV congestive heart failure, ventricular arrhythmias)
- Any history of liver or kidney disease resulting in persisting dysfunction
- Any active upper respiratory tract infection
- Pregnant or nursing females
- Known hypersensitivity to azithromycin, tobramycin or to any of the ingredients in the study medications
- Known hypersensitivity to erythromycin or any macrolide antibiotic
- Use of any antibiotic (topical or systemic) within 72 hours of enrollment
Cost to subject: No Subject Compensation: Yes - $300 Recruitment: Ongoing
Contact: Margaret Bozic, (843) 792-2095 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 Treatments/Procedures: Phacoemulsification and the implantation of an intraocular lens or the use of glasses or contact lenses. Randomization: Yes 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 Early Treatment of Retinopathy of Prematurity, Phase II
In the United States an estimated 1,300 infants annually develop retinopathy of prematurity (ROP) that is severe enough to require medical treatment. A study that clarifies whether earlier treatment is effective and safe is needed to guide clinical care.
To learn more about this trial please call Linda Stevens at (843) 792-2799 Purpose: To measure the recognition visual acuity in earlier-treated versus conventionally-treated eyes that experience severe ROP. To evaluate safety of earlier treatment.
Principal Investigator: Richard A. Saunders, MD Treatments/Procedures: Laser photocoagulation or cryotherapy Randomization: No Main Inclusion Criteria: Infants with retinopathy of prematurity Main Exclusion Criteria: System anomalies; ocular anomalies Cost to subject: None Subject Compensation: Yes - $100.00 Study Status: Open to accrual Contact: Linda Stevens, (843) 792-2799 | 
