NCT01485211

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Instituto de Olhos de Goiania · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Progressive Keratoconus
• Thin Corneas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-12-05
• Last updated: 2011-12-05