Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Keratoconus Clinical Trial

Official title:

Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05176171
• Other study ID #: SBMU
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: July 5, 2023

Study information

• Verified date: January 2022
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) will be divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures will be pre-and postoperative uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 5, 2023
• Est. primary completion date: March 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion criteria for the study focused on patients over 34 (range from 34 to 41) with stable corneal topography and refraction for at least six months and an estimated residual bed thickness of >410 µm.

exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Photorefractive Keratectomy with Corneal Cross-Linking
To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Negah Eye Hospital	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Shahid Beheshti University	Negah Eye Center, Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Evaluation of the uncorrected visual acuity, best corrected visual acuity, astigmatism, intraocular pressure and endothelial cell loss before and after the last operation.	3 year