Optimizing the Ocular Surface Prior to Cataract Surgery

Corneal Dystrophy, Epithelial Basement Membrane Clinical Trial

Official title:

Optimizing the Ocular Surface Prior to Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766907
• Other study ID #: P015-2
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2019
• Source: Tissue Tech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Corneal Dystrophy, Epithelial Basement Membrane

Intervention

Device:
• cryopreserved amniotic membrane
placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD

Locations

Country	Name	City	State
United States	Virginia Eye Consultants	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Tissue Tech Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Lens Calculation	Assessed by corneal topography	Change from Baseline to 1 month
Primary	Change in Intraocular Lens Power Calculation	Assessed using biometry and calculated using Holladay I formula	Change from Baseline to 1 month