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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

corneal cross linking

Procedure

Corneal Cross Linking combined with topoguided PRK

Procedure

Primary outcomes

Vision Specific quality of Life (VS-QoL)

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: May 3, 2013
Registry last updated: Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed