Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin

NCT01485211 | Completed Phase 4 DMC

• 1 other identifier: BQ - 5 - 11 -ARVO
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Conditions

Progressive Keratoconus; Thin Corneas

Keywords

progressive keratoconus; thin corneas; cross-linking; hypo-osmolar riboflavin

Outcome Measures

Primary Outcomes (1)

• Corneal thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas

  To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking treatment with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas with progressive keratoconus.

  Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Study Arms (1)

crosslinking with hypoosmolar riboflavin

EXPERIMENTAL

Riboflavin and UVA-induced corneal cross-linking increases the stability of keratoconic corneas. The current inclusion criteria require a minimum stromal thickness of 400 µm. Hypo-osmolar riboflavin solution increases the stromal thickness before CXL in cases with preoperatively thin corneas.

Drug: cross-linking with hypo-osmolar riboflavin

Interventions

cross-linking with hypo-osmolar riboflavin DRUG

Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Also known as: Riboflavin, UVA radiation

crosslinking with hypoosmolar riboflavin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Progressive Keratoconus
• thin corneas

You may not qualify if:

• Contact lens use for less than 3 weeks
• Non progressive keratoconus
• Thinest corneal thickness above 400 micra

Sponsors & Collaborators

• Instituto de Olhos de Goiania: lead

Related Publications (1)

• Nassaralla BA, Vieira DM, Machado ML, Figueiredo MN, Nassaralla JJ Jr. Corneal thickness changes during corneal collagen cross-linking with UV-A irradiation and hypo-osmolar riboflavin in thin corneas. Arq Bras Oftalmol. 2013 May-Jun;76(3):155-8. doi: 10.1590/s0004-27492013000300005.

  PMID: 23929075 DERIVED

MeSH Terms

Interventions

Riboflavin

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Belquiz A Nassaralla, MD, PhD

  Instituto de Olhos de Goiania

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: December 5, 2011
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 5, 2011

Record last verified: 2011-11