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

Progressive Keratoconus Clinical Trial

Official title:

Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Hypo-osmolar Riboflavin Solution in Thin Corneas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485211
• Other study ID #: BQ - 5 - 11 -ARVO
• Status: Completed
• Phase: Phase 4
• First received: November 23, 2011
• Last updated: December 2, 2011
• Start date: January 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.

After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Progressive Keratoconus

• thin corneas

Exclusion Criteria:

• Contact lens use for less than 3 weeks

• Non progressive keratoconus

• Thinest corneal thickness above 400 micra

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus
• Progressive Keratoconus
• Thin Corneas

Intervention

Drug:
• cross-linking with hypo-osmolar riboflavin
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes