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Status unknownNCT05176171Updated Apr 18, 2022

Surface Ablation With Corneal Cross Linking in Mild Keratoconus

An interventional study of Photorefractive Keratectomy with Corneal Cross-Linking in Keratoconus and Corneal Cross-Linking, sponsored by Shahid Beheshti University. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-18.

Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Mar 2018, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
30 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Keratoconus
  • Corneal Cross-Linking

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03

In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 50 is above the median of 40 across 203 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Shahid Beheshti University is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Photorefractive Keratectomy with Corneal Cross-Linking

    For correction of refractive error

    Procedure: Photorefractive Keratectomy with Corneal Cross-Linking

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 year

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Study locations

1 site
  • Negah Eye Hospital
    Tehran, 1544914599, Iran, Islamic Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05176171
Lead sponsor
Shahid Beheshti University
Collaborators
Negah Eye Center, Tehran University of Medical Sciences
Responsible party
farinaz doroodgar (Ophthalmologist, Shahid Beheshti University) — Principal investigator
First posted
Jan 4, 2022
Start date
Mar 5, 2018
Primary completion
Mar 5, 2019
Completion
Jul 5, 2023 (estimated)
Last update
Apr 18, 2022

Study contacts

Azad sanginabadi, PhD
principal investigator · Iran University of Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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