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Clinical Trials/NCT04405882
NCT04405882
Completed
Not Applicable

Combined Technique of Corneal Remodeling to Treat Ectasia

Bambino Gesù Hospital and Research Institute1 site in 1 country8 target enrollmentOctober 1, 2019
ConditionsCorneal Ectasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Ectasia
Sponsor
Bambino Gesù Hospital and Research Institute
Enrollment
8
Locations
1
Primary Endpoint
quality of vision
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Detailed Description

Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL). Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bambino Gesù Hospital and Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Luca Buzzonetti

Head of the Ofthalmology Departement

Bambino Gesù Hospital and Research Institute

Eligibility Criteria

Inclusion Criteria

  • keratoconus with moderate severity (Amsler-Krumeich stage I-II)

Exclusion Criteria

  • concomitant ocular disease
  • concomitant systemic disease
  • corneal opacities

Outcomes

Primary Outcomes

quality of vision

Time Frame: 6 months postoperatively

corneal morphological irregularity index (CMI)

Study Sites (1)

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