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Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05176171
Enrollment
50
Registered
2022-01-04
Start date
2018-03-05
Completion date
2023-07-05
Last updated
2022-04-18

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

Conditions

Corneal Cross-Linking, Keratoconus

Brief 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

Interventions

PROCEDUREPhotorefractive 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.

Sponsors

Negah Eye Center
CollaboratorOTHER
Tehran University of Medical Sciences
CollaboratorOTHER
Shahid Beheshti University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity3 yearEvaluation of the uncorrected visual acuity, best corrected visual acuity, astigmatism, intraocular pressure and endothelial cell loss before and after the last operation.

Countries

Iran

Outcome results

None listed

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