Corneal Tissue Inlay for Keratoconus

NCT02649738 | Unknown

• 1 other identifier: CLEI-Tissue-Inlay
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the outcomes of placing preserved corneal tissue within the keratoconic cornea in order to enhance thickness, stability, and optical conformation.

Conditions

Keratoconus

Keywords

keratoconus; corneal tissue inlay

Outcome Measures

Primary Outcomes (3)

• Corneal tissue inlay for keratoconus

  Change in maximum keratometry on corneal topography

  6 months

• Corneal tissue inlay for keratoconus

  Uncorrected visual acuity

  6 months

• Corneal tissue inlay for keratoconus

  Best spectacle corrected visual acuity

  6 months

Study Arms (1)

Corneal tissue inlay

EXPERIMENTAL

The treated cornea will be implanted with a thin disc of preserved corneal tissue

Procedure: Corneal tissue inlay

Interventions

Corneal tissue inlay PROCEDURE

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

Corneal tissue inlay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age, male or female, of any race
• Provide written informed consent and sign a HIPAA form
• Willingness and ability to follow all instructions and comply with schedule for follow-up visits
• For females: Must not be pregnant
• Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus.

You may not qualify if:

• Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
• If female, pregnant
• Eyes classified as either normal, atypical normal, keratoconus suspect or mild keratoconus on the severity grading scheme
• Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications For example: a history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.)
• A history of delayed corneal healing in the eye to be treated
• Have used an investigational drug or device within 30 days of the study

Sponsors & Collaborators

• Cornea and Laser Eye Institute: lead

Study Sites (1)

Cornea and Laser Eye Institue - Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

Related Publications (1)

• Greenstein SA, Yu AS, Gelles JD, Eshraghi H, Hersh PS. Corneal tissue addition keratoplasty: new intrastromal inlay procedure for keratoconus using femtosecond laser-shaped preserved corneal tissue. J Cataract Refract Surg. 2023 Jul 1;49(7):740-746. doi: 10.1097/j.jcrs.0000000000001187.

  PMID: 36943309 DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Peter Hersh, MD

  Cornea and Laser Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2022-12

Locations

US (1)