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

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02943967
Study type Interventional
Source Federal University of São Paulo
Contact
Status Completed
Phase N/A
Start date January 2010
Completion date January 2014
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