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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00832897
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Procedure: Corneal collagen crosslinking	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: "Evaluation of Topical Riboflavin Exposed to UVA Radiation and Implantation of Intrastromal Corneal Ring for Treatment of Keratoconus and Others Irregulars Astigmatisms."
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Eyedrop	Procedure: Corneal 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.; Other Names: Keratoconus. Corneal collagen crosslinking.
Active Comparator: Crosslinking The patients will be submitted to corneal collagen crosslinking, by use riboflavin eyedrop with UVA light.	Procedure: Corneal 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.; Other Names: Keratoconus. Corneal collagen crosslinking.

Outcome Measures

Primary Outcome Measures

1. Refractive data, visual acuity, topography patterns, pachymetry measurements. [Two years]

Secondary Outcome Measures

1. Anterior segment tomography data, corneal biomechanics, impression cytology. [Two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of São Paulo	São Paulo		Brazil	04038-000

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

• Principal Investigator: Adimara C Renesto, MD, Federal University of São Paulo
• Study Chair: Mauro S Campos, MD, Federal University of São Paulo
• Study Chair: Marta F Sartori, MD, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

• Coskunseven E, Kymionis GD, Tsiklis NS, Atun S, Arslan E, Jankov MR, Pallikaris IG. One-year results of intrastromal corneal ring segment implantation (KeraRing) using femtosecond laser in patients with keratoconus. Am J Ophthalmol. 2008 May;145(5):775-9. doi: 10.1016/j.ajo.2007.12.022. Epub 2008 Mar 4.
• Mencucci R, Mazzotta C, Rossi F, Ponchietti C, Pini R, Baiocchi S, Caporossi A, Menchini U. Riboflavin and ultraviolet A collagen crosslinking: in vivo thermographic analysis of the corneal surface. J Cataract Refract Surg. 2007 Jun;33(6):1005-8.

• ClinicalTrials.gov Identifier: NCT00832897
• Other Study ID Numbers: 1915/07
• First Posted: Jan 30, 2009
• Last Update Posted: Jan 7, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Keratoconus; riboflavin; cornea; crosslinking
• Additional relevant MeSH terms: Keratoconus

Study Results

No Results Posted as of Jan 7, 2011