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Gamma-Irradiated Corneal Inlay for Keratoconus

NCT04895514 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-11-14

No results posted yet for this study

Summary

Study objective is to evaluate the outcomes of placing gamma-irradiated corneal tissue (VisionGraft, CorneaGen, USA) within the cornea of patients with keratoconus, a procedure called Corneal Tissue Addition for Keratoconus (CTAK).

Conditions

  • Keratoconus

Interventions

PROCEDURE

Gamma-irradiated corneal tissue inlay

A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of gamma-irradiated preserved corneal tissue will then be placed into the pocket

Sponsors & Collaborators

  • Cornea and Laser Eye Institute

    lead OTHER

Principal Investigators

  • Peter S Hersh, MD · Cornea and Laser Eye Institute

  • Steven A Greenstein, MD · Cornea and Laser Eye Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-06-01
Completion
2023-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895514 on ClinicalTrials.gov