Refractive Treatment of Early Keratoconus

Keratoconus Clinical Trial

Official title: iDesign Aberrometer for the Refractive Treatment of Early Keratoconus

Status Not yet recruiting

Clinical Trial Summary

Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to significant visual deterioration over time. Corneal collagen crosslinking with riboflavin (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the need for corneal transplantation. However, the treatment alone has little impact in terms of improving visual function. Photorefractive keratectomy (PRK) is the application of an excimer laser to treat a patient's refractive error, therefore decreasing the dependence on spectacles or contact lenses for improved vision.

Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to partially correct the refractive error in keratoconic patients, whilst simultaneously stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced high-resolution aberrometer. It is capable of mapping highly aberrated corneas for wavefront-guided laser procedures, and represents an important technological advance in treating corneal disease.

The purpose of this single center, prospective pilot study is to assess the safety and efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using the iDesign® aberrometer. Results of this pilot study will be used to provide sample size estimates for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes.

Clinical Trial Description

The purpose of this pilot study is to assess the visual outcomes of combined wavefront-guided PRK and CXL in Krumeich stage 1 and 2 keratoconic eyes. The investigators will be conducting a prospective study at the University of Ottawa Eye Institute. A total of 24 patients will be enrolled in the study divided into two groups:

Group 1: PRK performed12-18 months after CXL; Group 2: PRK performed or on the same day as CXL

Participants will be followed at regular intervals for 1 year and information regarding visual, refractive, keratometric and higher order aberration outcomes will be collected.

The researchers aim to investigate the safety and efficacy of combined wavefront guided PRK and CXL. Results of this pilot study will used to provide estimates for sample size calculation for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes. ;

Study Design

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

Related Conditions & MeSH terms

• Keratoconus

• NCT number: NCT02613780
• Study type: Interventional
• Source: Ottawa Hospital Research Institute
• Contact: Setareh Ziai, MD, FRCSC
• Email: ziaieye@gmail.com
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2016
• Completion date: January 2019