Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Procedure: Corneal Cross Linking; Procedure: Corneal Cross Linking combined with topoguided PRK

• Registration Number: NCT01845714
• Lead Sponsor: Democritus University of Thrace

Brief Summary

Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2011-04
• Study Completion: 2012-10
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-14
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus
• present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.

Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:

• an increase of 1.00 diopter (D) or more in the steepest keratometry measurement
• an increase of 1.00 D or more in manifest cylinder
• an increase of 0.50 D or more in manifest refraction spherical equivalent.

Exclusion Criteria

• glaucoma
• suspicion for glaucoma
• IOP-lowering medications
• central corneal thickness (CCT) less than 400μm
• K-readings more than 60D
• history of herpetic keratitis
• corneal scarring
• severe eye dryness
• pregnancy or nursing
• current corneal infection
• or underlying autoimmune disease KG members were further sub-divided into CxL and tCxL groups, according to their eligibility for treatment with CxL or CxL with tPRK. In order to be eligible for tCxL, group participants should, additionally, have CCT above 450μm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cross Linking Group (CxL group)	Corneal Cross Linking	Patients that received CXL
Cross Linking with topo-guided PRK (tCxL)	Corneal Cross Linking combined with topoguided PRK	Patients that received tCxL

Primary Outcome Measures

Name	Time	Method
Vision Specific quality of Life (VS-QoL)	3 years