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

Instituto de Olhos de Goiania

Status and phase: Completed; Phase 4

Conditions: Progressive Keratoconus; Thin Corneas

Treatments: Drug: cross-linking with hypo-osmolar riboflavin

Study type: Interventional

Funder types: Other

Identifiers

NCT01485211

BQ - 5 - 11 -ARVO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

crosslinking with hypoosmolar riboflavin

Experimental group

Description:

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.

Treatment:

Drug: cross-linking with hypo-osmolar riboflavin