Optimizing the Ocular Surface Prior to Cataract Surgery

Not Applicable

Completed

• Conditions: Corneal Dystrophy, Epithelial Basement Membrane

• Registration Number: NCT02766907
• Lead Sponsor: Tissue Tech Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-10
• Primary Completion: 2017-01
• Study Completion: 2018-04
• Results First Submitted: 2019-01-18
• Results First Submitted QC: 2019-02-13
• Status Verified: 2019-03
• Results First Posted: 2019-03-05
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

1. Subjects with known intolerance to PKS or known allergy to its preservative media.
2. Subjects with symblepharon or lid abnormality preventing PKS placement.
3. Ocular infection within 14 days prior to study entry.
4. Previous ocular surgery or injury within 3 months before enrollment.
5. Subjects with a history of non-healing epithelial defect or neurotrophic keratitis.
6. Inability or unwillingness of subject to give written informed consent, follow investigational plan or complete postoperative follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Lens Calculation	Change from Baseline to 1 month	Assessed by corneal topography
Change in Intraocular Lens Power Calculation	Change from Baseline to 1 month	Assessed using biometry and calculated using Holladay I formula

Trial Locations

Locations (1)

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States