CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Transepithelial Photorefractive Keratectomy (TransPRK) +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02208089
NCT02208089N/ACompleted

A Prospective Trial of Simultaneous Combined Transepithelial Photorefractive Keratectomy and Corneal Collagen Cross-linking for Keratoconus

Bruce Allan·interventional·Posted Aug 4, 2014·Updated Feb 8, 2019

In Brief

A clinical study evaluating Transepithelial Photorefractive Keratectomy (TransPRK) and Corneal Collagen Cross-Linking (CXL) for Keratoconus. Completed, enrolled 55 participants across 1 site.

Detailed Summary

Young patients with keratoconus face two problems: disease progression and corneal shape irregularity leading to poor vision even in spectacles. Corneal collagen cross-linking (CXL) is a new treatment designed to halt disease progression in keratoconus. The aim is to stiffen the cornea thereby preventing further shape deterioration. Topography or wavefront guided transepithelial photorefractive keratectomy (transPRK) uses the excimer laser (the laser used to correct sight in 'laser eye surgery') to reduce corneal shape irregularity in early stage keratoconus, reducing dependence on contact lenses. In transPRK, the corneal skin layer is removed in a well controlled, no touch procedure, preparing the cornea for CXL. Performing both treatments simultaneously (combining both procedures in one operation) may offer several advantages over performing CXL first then waiting for corneal shape to stabilise before performing transPRK. In particular, visual rehabilitation may be faster. This study aims to evaluate visual recovery after simultaneous CXL and transPRK in progressive early stage keratoconus. Visual recovery in these patients will be compared with results for a similar group of patients with early stage keratoconus who have already been treated with CXL alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconus
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartAug 1, 2014
Primary CompletionJul 1, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.9 years ago

Interventions

Transepithelial Photorefractive Keratectomy (TransPRK)procedure

Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).

Corneal Collagen Cross-Linking (CXL)procedure

Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure. UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)