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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Keratoconus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cross Linking Group (CxL group)

Patients that received CXL

Group Type ACTIVE_COMPARATOR

Corneal Cross Linking

Intervention Type PROCEDURE

Cross Linking with topo-guided PRK (tCxL)

Patients that received tCxL

Group Type ACTIVE_COMPARATOR

Corneal Cross Linking combined with topoguided PRK

Intervention Type PROCEDURE

Interventions

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Corneal Cross Linking

Intervention Type PROCEDURE

Corneal Cross Linking combined with topoguided PRK

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No