A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel Group Evaluation of the Safety and Efficacy of OT-551 Ophthalmic Solution to Prevent Formation or Delay Progression of Nuclear Cataract Formation in Post-Vitrectomy Patients
Study Summary
The University of Chicago and Dr. Seenu Hariprasad are conducting a study to look at the safety of experimental eye drops for cataract prevention and progression in subjects with cataracts undergoing vitrectomy (a surgical procedure during which a gel-like transparent substance that fills the eye called vitreous is removed). Cataract occurs when the part of the eye called the lens starts to lose its transparency, becomes cloudy, and impairs vision. The lens of the eye performs a crucial function in vision by focusing images of the external world on the retina (innermost area of the eye). Thus, cataracts diminish vision quality by blurring the images formed on the retina. Furthermore, people who already have cataracts seem to be at a greater risk for progression of cataracts that have been formed after undergoing vitrectomy surgery.
The experimental eye drops we are testing are thought to prevent cataracts from forming or slow-down the progression of cataracts that have already formed.
Dr. Hariprasad invites you to participate in a research study if you have been diagnosed by your doctor as having cataracts and planning on having vitrectomy. There will be nine planned visits in the study. If you qualify for the study and decide to participate, you will be randomly assigned by chance (like flipping a coin) to receive either higher concentration of study eye drops, lower concentration of eye drops, or a placebo--which would look like study eye drops, but will not have active substance present in the study eye drops. You will start using study eye drops three times a day approximately one week before vitrectomy and will continue using study eye drops for the duration of the study. Participants are expected to be in the study for one year.
You may receive no benefit from participating in this study.
Participation Details
To be considered for enrollment into the study, you must:
- Be at least 50 years of age
- Give written informed consent
- Have cataracts and be scheduled to undergo vitrectomy
- Be available for study visits for the duration of the study
- Not be pregnant or breastfeeding during the study
- Meet study eligibility criteria as evaluated by Dr. Hariprasad
- Understand the study instructions and be able to follow the study instructions
Study Director: Seenu Hariprasad, MD
Department: Ophthalmology
For more information contact:
Sophie Gen, CCRP
sgen@bsd.uchicago.edu
(773) 702-7666
IRB: #14200B
