Cornea Ectasia Excimer Laser Treatment

Corneal Ectasia Clinical Trial

Official title:

Combined Technique of Corneal Remodeling to Treat Ectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405882
• Other study ID #: L1
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 30, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 66 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• concomitant ocular disease

• concomitant systemic disease

• corneal opacities

Related Conditions & MeSH terms

• Corneal Ectasia

Intervention

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.

Locations

Country	Name	City	State
Italy	Luca buzzonetti	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of vision	uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)	preoperatively
Primary	quality of vision	Efficacy and Safety index.	preoperatively
Primary	quality of vision	corneal morphological irregularity index (CMI)	preoperatively
Primary	quality of vision	uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)	6 months postoperatively
Primary	quality of vision	Efficacy and Safety index.	6 months postoperatively
Primary	quality of vision	corneal morphological irregularity index (CMI)	6 months postoperatively