Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus

NCT06267495

Keratoconus

COMPLETED

Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management

NCT06549387

Amount of Corneal Flattening (Kmax Flattening) Change in the Endothelial Cell Count

NOT_YET_RECRUITING NA

One-Year Outcomes After Conventional vs Accelerated Epi-Off Corneal Cross-Linking in Progressive Keratoconus (Observational Cohort)

NCT07194538

Keratoconus

COMPLETED

Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus

NCT02189447

Keratoconus

COMPLETED NA

Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS

NCT05019768

Keratoconus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Keratoconus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epi-on cross-linking

Intervention: Drug: Riboflavin 0.15 in 20% dextran solution

Group Type ACTIVE_COMPARATOR

administration of riboflavin for epi-off cross-linking

Intervention Type PROCEDURE

riboflavin 0.1% in 20% dextran solution

administration of riboflavin for epi-on cross-linking

Intervention Type PROCEDURE

riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid

Epi-off cross-linking

intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid

Group Type ACTIVE_COMPARATOR

administration of riboflavin for epi-off cross-linking

Intervention Type PROCEDURE

riboflavin 0.1% in 20% dextran solution

administration of riboflavin for epi-on cross-linking

Intervention Type PROCEDURE

riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

administration of riboflavin for epi-off cross-linking

riboflavin 0.1% in 20% dextran solution

Intervention Type PROCEDURE

administration of riboflavin for epi-on cross-linking

riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with evolving keratoconus
* aged between 18 and 40 years
* no evidence of corneal scarring

Exclusion Criteria

* patients with central and paracentral corneal opacities
* Vogt's striae
* previous intraocular surgery
* history of herpetic keratitis
* history of severe dry eye
* concomitant autoimmune diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No