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

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneal Cross Linking
Corneal Cross Linking combined with topoguided PRK
Sponsored by
Democritus University of Thrace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Keratoconus focused on measuring Keratoconus, Corneal cross Linking, Topo guided PRK, Quality of Life

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cross Linking Group (CxL group)

    Cross Linking with topo-guided PRK (tCxL)

    Arm Description

    Patients that received CXL

    Patients that received tCxL

    Outcomes

    Primary Outcome Measures

    Vision Specific quality of Life (VS-QoL)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 30, 2013
    Last Updated
    January 14, 2017
    Sponsor
    Democritus University of Thrace
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01845714
    Brief Title
    Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    October 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Democritus University of Thrace

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    Keratoconus, Corneal cross Linking, Topo guided PRK, Quality of Life

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cross Linking Group (CxL group)
    Arm Type
    Active Comparator
    Arm Description
    Patients that received CXL
    Arm Title
    Cross Linking with topo-guided PRK (tCxL)
    Arm Type
    Active Comparator
    Arm Description
    Patients that received tCxL
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneal Cross Linking
    Intervention Type
    Procedure
    Intervention Name(s)
    Corneal Cross Linking combined with topoguided PRK
    Primary Outcome Measure Information:
    Title
    Vision Specific quality of Life (VS-QoL)
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23807006
    Citation
    Labiris G, Giarmoukakis A, Sideroudi H, Kozobolis V. Impact of keratoconus, cross-linking and cross-linking combined with topography-guided photorefractive keratectomy on self-reported quality of life: a 3-year update. Cornea. 2013 Sep;32(9):e186-8. doi: 10.1097/ICO.0b013e318296e13c. No abstract available.
    Results Reference
    result

    Learn more about this trial

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

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