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 range50 Years

SexALL

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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.
✕. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.

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