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

January 14, 2017 updated by: Georgios Labiris, Democritus University of Thrace
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cross Linking Group (CxL group)
Patients that received CXL
Procedure: Corneal Cross Linking
ACTIVE_COMPARATOR: Cross Linking with topo-guided PRK (tCxL)
Patients that received tCxL
Procedure: Corneal Cross Linking combined with topoguided PRK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vision Specific quality of Life (VS-QoL)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

April 30, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIT-KC-VSQOL3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Keratoconus

Clinical Trials on Corneal Cross Linking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe