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Cornea Ectasia Excimer Laser Treatment

Combined Technique of Corneal Remodeling to Treat Ectasia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04405882
Enrollment
8
Registered
2020-05-28
Start date
2019-10-01
Completion date
2020-04-30
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Ectasia

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.

Interventions

PROCEDUREtopographic guided trans epithelial excimer laser

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.

Sponsors

Bambino Gesù Hospital and Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 66 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* concomitant ocular disease * concomitant systemic disease * corneal opacities

Design outcomes

Primary

MeasureTime frameDescription
quality of visionpreoperativelyuncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026