NCT02943967

Corneal Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneas

Two Years Follow up of Corneal Cor Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneal Topography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 23 Years – 51 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and photorefractive keratectomy for refractive correction in patients with bilateral asymmetric topography.

Detailed description

Corneal cross-linking (CXL) by the photosensitizer, riboflavin (vitamin B2), and ultraviolet A (UVA) light increases corneal rigidity and has been described as an effective method for stabilizing the cornea in patients with progressive keratoconus. The photochemical reaction in this procedure causes the collagen to form additional covalent connections between its fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and the cornea rigidity. It is a relatively safe procedure with low rates of complications Photorefractive keratectomy (PRK) it is a traditional technique for refractive surgery. In cases of irregular corneas or re-operation normally the favorite ablation profile chosen is the guided surgery, topography guided or wavefront guided, showing better results. This technique is also relatively safe procedure with low rates of complications. One of the most unwanted complications of this surgery and also rare is corneal ectasia. Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus. This combined procedure uses the principle that CXL stiffen the cornea making it possible to reduce corneal thickness with PRK without weakening corneal strength. Literature show better results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in keratoconus suspects and within 5 years he did not found any corneal ectasia.

Conditions

• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
PROCEDURE	CXL + PRK group	Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye
PROCEDURE	PRK group	Photorefractive keratotomy alone was performed in contra lateral eyes

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2016-10-25
• Last updated: 2016-10-26

Locations

1 site across 1 country: Brazil