Refractive Corneal Cross-linking for Progressive Keratoconus

NCT03531047 | Completed

• 1 other identifier: GORD1003
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Young patients with keratoconus face two problems: disease progression and corneal shape irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required to maintain useful vision. Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease progression. The aim is to strengthen the cornea to prevent further shape deterioration. For patients whose quality of vision has already suffered, standard CXL can generally only prevent further deterioration, rather than improving vision. Refractive CXL, a new iteration of CXL in which a bespoke treatment pattern is applied to the cornea, aims to smooth out surface irregularities thereby improving vision. This primary objective of this study is to compare the visual outcome in patients with progressive keratoconus treated with refractive CXL, as compared with historical controls treated with standard CXL.

Conditions

Keratoconus

Keywords

progressive; cross-linking; customised; refractive

Outcome Measures

Primary Outcomes (1)

• Change in corrected distance visual acuity

  LogMAR corrected vision in spectacles

  24 months

Secondary Outcomes (4)

• Change in uncorrected distance visual acuity

  24 months

• Manifest refraction

  24 months

• Tomography

  24 months

• Rates of keratitis

  24 months

Study Arms (1)

Refractive CXL

EXPERIMENTAL

Tomography-customised CXL

Procedure: Customised CXL

Interventions

Customised CXL PROCEDURE

As for standard CXL, following mechanical removal of the corneal surface layer (epithelium), 0.1% riboflavin drops will be applied every 2 minutes for 10 minutes prior to ultraviolet A (UVA) irradiation - UVA power, distribution and timing as determined by analysis of Pentacam tomography scans. A bandage contact lens will be applied to encourage regrowth of the corneal surface and reduce post-operative pain.

Also known as: Riboflavin drops (drug): Vibex Rapid (Avedro Inc.)

Refractive CXL

Eligibility Criteria

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

You may qualify if:

• Patients with progressive stage I - III keratoconus
• Corrected distance visual acuity (CDVA) \< 0.00 logMAR

You may not qualify if:

• Patients under the age of 18 years
• Active ocular surface disease
• Minimum corneal thickness \< 375 µm
• Vulnerable groups
• Pregnancy

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

Related Publications (2)

• Gore DM, Shortt AJ, Allan BD. New clinical pathways for keratoconus. Eye (Lond). 2013 Mar;27(3):329-39. doi: 10.1038/eye.2012.257. Epub 2012 Dec 21.

  PMID: 23258309 RESULT

• O'Brart DP, Chan E, Samaras K, Patel P, Shah SP. A randomised, prospective study to investigate the efficacy of riboflavin/ultraviolet A (370 nm) corneal collagen cross-linkage to halt the progression of keratoconus. Br J Ophthalmol. 2011 Nov;95(11):1519-24. doi: 10.1136/bjo.2010.196493. Epub 2011 Feb 24.

  PMID: 21349938 RESULT

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Daniel M Gore

  Moorfields Eye Hospital NHS Foundation Trust

  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: May 8, 2018
• First Posted: May 21, 2018
• Study Start: November 1, 2018
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)