Cornea Ectasia Excimer Laser Treatment
Combined Technique of Corneal Remodeling to Treat Ectasia
1 other identifier
observational
8
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedMay 28, 2020
May 1, 2020
1 month
May 18, 2020
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
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
Interventions
In this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) 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 respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
Eligibility Criteria
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.
You may qualify if:
- \- keratoconus with moderate severity (Amsler-Krumeich stage I-II)
You may not qualify if:
- concomitant ocular disease
- concomitant systemic disease
- corneal opacities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Luca buzzonetti
Roma, RM, 00195, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Ofthalmology Departement
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 28, 2020
Study Start
October 1, 2019
Primary Completion
October 31, 2019
Study Completion
April 30, 2020
Last Updated
May 28, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share