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Adapted Fluence Settings for Corneal Collagen Cross-linking in Mild to Moderate Progressive Keratoconus

NCT02507362 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-07-23

No results posted yet for this study

Summary

the purpose of this study is to compare the efficacy and safety of a new method of corneal cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)

Conditions

  • Keratoconus

Interventions

RADIATION

adjusted corneal collagen cross-linking

UV-A irradiation for 7 minutes

RADIATION

accelerated corneal collagen cross-linking

UV-A irradiation for 10 minutes

DRUG

riboflavin 0.1% combined with dextran 20 %

after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation

PROCEDURE

epithelial debridement

corneal epithelium will be removed by a cottons swab

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Fateme Alipour, MD · Eye research center, Farabi eye hospital, Tehran university of medical science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • Iran

Study Locations

More Related Trials

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 NCT02507362 on ClinicalTrials.gov