Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Corneal Ring

Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832897

Enrollment

Registered

2009-01-30

Start date

2008-03-31

Completion date

2010-10-31

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, riboflavin, cornea, crosslinking

Brief summary

The purpose of this study is to postpone the corneal transplantation in keratoconus and promote the stiffness of the cornea across the riboflavin-UVA corneal collagen crosslinking , and after, corneal ring surgery.

Detailed description

Keratoconus is a progressive disease where cornea is thin and has a higher curvature.In early conditions, it may be corrected by glasses or contact lens.When these possibilities are not more possibles, it may be corrected by corneal ring surgery ore corneal transplantation depending your degree. In this study, the patients with a degree of keratoconus on I or II, will be submitted to corneal collagen crosslinking and then a corneal ring surgery. The corneal collagen crosslinking promote the stiffness of the cornea across the riboflavin-UVA irradiation, avoid the progression of the keratoconus.After three months of crosslinking, these patients will be submitted a corneal ring surgery. These patients will be allowed by two years and various exams will realized them.

Interventions

PROCEDURECorneal collagen crosslinking

The patients will be submitted to corneal collagen crosslinking, that consists: Instillation of riboflavin eyedrop in the cornea for thirty minutes, and after, the patient will stay under the Crosslinking equipment, for more thirty minutes, also receiving riboflavin eyedrop.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Patients with keratoconus * Patients that aren't using contact lenses * Pachymetry more than 400Um * Best visual acuity less or equal 20/30

Exclusion criteria

* Ocular surgeries before * Other eye diseases * Corneal curvature more than 65 dioptres

Design outcomes

Primary

Measure	Time frame
Refractive data, visual acuity, topography patterns, pachymetry measurements.	Two years

Secondary

Measure	Time frame
Anterior segment tomography data, corneal biomechanics, impression cytology.	Two years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026