- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527721
Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus
Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CXL Combined With Photorefractive Keratectomy (PRK) in Keratoconus.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandroupolis, Greece
- Eye Institute of Thrace (EIT)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CxL group
Volunteers of this group received CxL treatment.
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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.
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Experimental: tCxL group
Volunteers of this group received CxL combined with t-PRK treatment
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Higher order corneal aberations
Time Frame: 1 year postoperatively
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1 year postoperatively
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3/2/2012 37
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
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The Cleveland ClinicUniversity of MarylandEnrolling by invitationKeratoconus | Keratoconus, Unstable | Keratoconus, StableUnited States
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Tianjin Eye HospitalRecruitingScansys, Pentacam, Keratoconus, Subclinical KeratoconusChina
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Tianjin Eye HospitalActive, not recruitingScansys, Pentacam, Corvis ST, Keratoconus, Subclinical KeratoconusChina
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Heba Allah Nashaat MohamedAssiut UniversityRecruitingKeratoconus, CollagenEgypt
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Kent Wellish MDNot yet recruitingKeratoconus, Unstable
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Kasr El Aini HospitalUnknownProgressive KeratoconusEgypt
-
Centre Hospitalier Régional Metz-ThionvilleCompletedProgressive Keratoconus
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Glaukos CorporationCompletedProgressive KeratoconusUnited States
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Tianjin Eye HospitalCompletedKeratoconus, StableChina
Clinical Trials on Corneal Collagen Cross-Linking (CxL)
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Benha UniversityCompletedCollagen Diseases | Keratoconus | Corneal DiseaseEgypt
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Bruce AllanMoorfields Eye Hospital NHS Foundation TrustCompleted
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Oslo University HospitalRecruiting
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Yonsei UniversityCompletedModerate KeratoconusKorea, Republic of
-
Shahid Beheshti University of Medical SciencesUnknownKeratoconusIran, Islamic Republic of
-
Minia UniversityRecruiting
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Medical University of ViennaTerminatedKeratoconus | Pellucid Marginal DegenerationAustria
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Democritus University of ThraceCompleted
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Democritus University of ThraceCompleted