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NCT Number: NCT04405882

Cornea Ectasia Excimer Laser Treatment

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).

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Key information

Conditions

Corneal Ectasia

Age range

19 year–66 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Luca buzzonetti

Roma, RM, 00195, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • concomitant ocular disease
  • concomitant systemic disease
  • corneal opacities

Treatment and study plan

topographic guided trans epithelial excimer laser

Procedure

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.

Other names: corneal cross linking

Primary outcomes

  1. quality of vision

    Time frame: preoperatively

    uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)

  2. quality of vision

    Time frame: preoperatively

    Efficacy and Safety index.

  3. quality of vision

    Time frame: preoperatively

    corneal morphological irregularity index (CMI)

  4. quality of vision

    Time frame: 6 months postoperatively

    uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)

  5. quality of vision

    Time frame: 6 months postoperatively

    Efficacy and Safety index.

  6. quality of vision

    Time frame: 6 months postoperatively

    corneal morphological irregularity index (CMI)

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

Combined Technique of Corneal Remodeling to Treat Ectasia

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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