Cornea Ectasia Excimer Laser Treatment

Combined Technique of Corneal Remodeling to Treat Ectasia

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).

Study Overview

• Status: Completed
• Conditions: Corneal Ectasia
• Intervention / Treatment: Procedure: topographic guided trans epithelial excimer laser

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00195
      • Luca buzzonetti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eight eyes (2 right and 6 left eyes) of 8 patients, 5 male and 3 female (mean age 31.50±14.73, range 19 to 66 years), affected by cornea ectasia were enrolled in this study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• concomitant ocular disease
• concomitant systemic disease
• corneal opacities

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of vision	uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)	preoperatively
quality of vision	Efficacy and Safety index.	preoperatively
quality of vision	corneal morphological irregularity index (CMI)	preoperatively
quality of vision	uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)	6 months postoperatively
quality of vision	Efficacy and Safety index.	6 months postoperatively
quality of vision	corneal morphological irregularity index (CMI)	6 months postoperatively

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: L1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No