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NCT02189447 Clinical Trial

Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus

Keratoconus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02189447
Other study ID # TEC 126
Secondary ID
Status Completed
Phase N/A
First received July 5, 2014
Last updated July 10, 2014
Start date January 2011
Est. completion date September 2013

Study information
Verified date July 2014
Source The Eye Center and The Eye Foundation for Research in Ophthalmology
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Ministry of Health
Study type Interventional

Clinical Trial Summary

Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- contact lens intolerance

- corneal thickness > 450 micrometers

- Keratometry < 56 diopters

- Astigmatism < 6 diopters

Exclusion Criteria:

- corneal thickness < 450 micrometers

- Keratometry > 56 diopters

- Astigmatism > 6 diopters

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Eye Center and The Eye Foundation for Research in Ophthalmology

Outcome
Type Measure Description Time frame Safety issue
Primary The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking. 6 months No
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Completed NCT01527708 - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas N/A
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Withdrawn NCT01789333 - Higher Irradiance in Keratoconus Ectasia N/A
Completed NCT05114928 - Correlation Between Q-value Changes and Progression of Pediatric Keratoconus.
Completed NCT03647046 - Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus N/A
Recruiting NCT04439552 - fMRI and IVCM Cornea Microscopy of CXL in Keratoconus
Recruiting NCT06100939 - Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus Phase 3