Clinical Trials Directory

Trials / Completed

CompletedNCT04405882

Cornea Ectasia Excimer Laser Treatment

Combined Technique of Corneal Remodeling to Treat Ectasia

Status
Completed
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
Bambino Gesù Hospital and Research Institute · Academic / Other
Sex
All
Age
19 Years – 66 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREtopographic guided trans epithelial excimer laserIn 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.

Timeline

Start date
2019-10-01
Primary completion
2019-10-31
Completion
2020-04-30
First posted
2020-05-28
Last updated
2020-05-28

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04405882. Inclusion in this directory is not an endorsement.