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Cornea Ectasia Excimer Laser Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405882
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Luca Buzzonetti, Bambino Gesù Hospital and Research Institute

Study Description
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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).

Condition or disease Intervention/treatment
Corneal Ectasia 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 Design
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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Combined Technique of Corneal Remodeling to Treat Ectasia
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: topographic 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.
    Other Name: corneal cross linking

Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • concomitant ocular disease
  • concomitant systemic disease
  • corneal opacities
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405882


Locations
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Italy
Luca buzzonetti
Roma, RM, Italy, 00195
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
More Information
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Responsible Party: Luca Buzzonetti, Head of the Ofthalmology Departement, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT04405882    
Other Study ID Numbers: L1
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical