Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Corneal Collagen Cross-Linking (CxL)
Corneal Collagen Cross-Linking combined with t-PRK
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, CxL, CxL combined with t-PRK
Eligibility Criteria
Inclusion Criteria:
- progressive keratoconus
Exclusion Criteria:
- glaucoma or suspicion for glaucoma,
- central corneal thickness (CCT) less than 400μm,
- K-readings more than 60D,
- history of herpetic keratitis,
- pregnancy or nursing,
- underlying autoimmune disease
Sites / Locations
- Eye Institute of Thrace (EIT)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CxL group
tCxL group
Arm Description
Volunteers of this group received CxL treatment.
Volunteers of this group received CxL combined with t-PRK treatment
Outcomes
Primary Outcome Measures
Higher order corneal aberations
Secondary Outcome Measures
Full Information
NCT ID
NCT01527721
First Posted
February 3, 2012
Last Updated
January 14, 2017
Sponsor
Democritus University of Thrace
1. Study Identification
Unique Protocol Identification Number
NCT01527721
Brief Title
Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus
Official Title
Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CXL Combined With Photorefractive Keratectomy (PRK) in Keratoconus.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Democritus University of Thrace
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objective of this study was to assess the impact of the two prevalent therapeutic options, CxL and CxL combined with topography-guided photorefractive keratectomy (t-PRK), on both anterior and posterior corneal High order aberations (HOAs).
Detailed Description
The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.32 patients with keratoconus were included in the study. Of them, 19 patients underwent CxL treatment (CxL group), while the rest 13 patients underwent CxL combined with t-PRK (tCxL) [tCxL group]. If both eyes were eligible, only one eye was enrolled in the study.Regarding Scheimpflug camera (Pentacam Classic, Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04 ) measurements, acceptable maps had at least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone were excluded.
For both anterior and posterior corneal surfaces, Pentacam-derived HOAs parameters for both pupil diameters of 4mm and 6mm were calculated, as well as the HOA root mean square (RMS)values. Pentacam-derived HOA measurements were obtained one day prior to treatment and then one year post-op.The impact of the surgical technique (either CXL or tCXL) on spherocylindrical error was evaluated by power vector analysis as described before. Furthermore, manifest refractions comprising of sphere (S), cylinder (C) and axis (φ), were converted into three dioptric powers (M, J0 and J45). Moreover, we calculated the overall blurring strength (B) of the spherocylindrical error by measuring the length of the produced vector.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, CxL, CxL combined with t-PRK
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CxL group
Arm Type
Experimental
Arm Description
Volunteers of this group received CxL treatment.
Arm Title
tCxL group
Arm Type
Experimental
Arm Description
Volunteers of this group received CxL combined with t-PRK treatment
Intervention Type
Procedure
Intervention Name(s)
Corneal Collagen Cross-Linking (CxL)
Intervention Description
The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. The UVA radiation source was UV-XTM Zurich, . Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well, in order to sustain the necessary concentration of the riboflavin. Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.
Intervention Type
Procedure
Intervention Name(s)
Corneal Collagen Cross-Linking combined with t-PRK
Intervention Description
For tCxL group, the topo-guided PRK preceded the CXL. The epithelium was mechanically removed with a hockey knife and ablation was performed in a 9.0 mm zone with a maximal intended ablation depth of 50μm. No adjuvant Mitomycin-C was applied in any case. For the photorefractive ablation we used the Allegretto Wave 200 Hz (1.0071-1-0.81/1.208 software/ WaveLight AG, Erlangen, Germany) with the T-CAT ablation profile.
Primary Outcome Measure Information:
Title
Higher order corneal aberations
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
progressive keratoconus
Exclusion Criteria:
glaucoma or suspicion for glaucoma,
central corneal thickness (CCT) less than 400μm,
K-readings more than 60D,
history of herpetic keratitis,
pregnancy or nursing,
underlying autoimmune disease
Facility Information:
Facility Name
Eye Institute of Thrace (EIT)
City
Alexandroupolis
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
27099464
Citation
Labiris G, Sideroudi H, Angelonias D, Georgantzoglou K, Kozobolis VP. Impact of corneal cross-linking combined with photorefractive keratectomy on blurring strength. Clin Ophthalmol. 2016 Apr 1;10:571-6. doi: 10.2147/OPTH.S100770. eCollection 2016.
Results Reference
result
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Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus
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