CompletedNot Applicable

Optimizing the Ocular Surface Prior to Cataract Surgery

United States20 participantsStarted 2016-03

Plain-language summary

Prospective study to evaluate the efficacy of using self-retained cryopreserved amniotic membrane after debridement in treating Epithelial Base Membrane Dystrophy (EBMD) to optimize the ocular surface integrity and intraocular lens calculation before cataract surgery.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects with significant EBMD that are contemplating cataract surgery.
. Age range: 50 years and older.
. Both Genders and all ethnic groups comparable with the local community.
. Subjects able to understand and willing to sign a written informed consent.
. Subjects able and willing to cooperate with the investigational plan.
. Subjects able and willing to complete postoperative follow-up.

Exclusion criteria

. Subjects with known intolerance to PKS or known allergy to its preservative media.
. Subjects with symblepharon or lid abnormality preventing PKS placement.
. Ocular infection within 14 days prior to study entry.
. Previous ocular surgery or injury within 3 months before enrollment.
. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Intraocular Lens Calculation

Timeframe: Change from Baseline to 1 month

Change in Intraocular Lens Power Calculation

Timeframe: Change from Baseline to 1 month

Trial details

NCT IDNCT02766907

SponsorBioTissue Holdings, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01

Results submitted2019-01-18

View on ClinicalTrials.gov More Corneal Dystrophy, Epithelial Basement Membrane trials