Comparison of effects & complications of Collagen Cross-Linking surgery with 2 methods of Epithelium removal & Trans Epithelial with using DAYA epithelium disruptor: A Randomized- Controlled Clinical Trial

Comparison of effects & complications of CCL surgery with 2 methods of Epithelium removal & Trans Epithelial with using DAYA epithelium disruptor: A Randomized-Controlled Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016112231028N1

Enrollment

Registered

2017-03-29

Start date

2017-02-15

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

keratoconus. No description was found

Interventions

Intervention 1: Control Group: Corneal epithelium is removed completely by FUKASAKU Hockey Knife and then standard solution of riboflavin 0.1% with intervals of 3 minutes distilled into eye for 30 min

Treatment - Surgery

Control Group: Corneal epithelium is removed completely by FUKASAKU Hockey Knife and then standard solution of riboflavin 0.1% with intervals of 3 minutes distilled into eye for 30 min. Then with irra

Intervention Group: Corneal epithelium is disrupted incompletely by DAYA epithelial disruptor and then standard solution of riboflavin 0.1% with intervals of 3 minutes distilled into eye for 30 min. T

Eligibility

Sex/Gender

All

Age

18 Years to 46 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Those with Rabinowitz criteria of keratoconus of both eyes; age = 25 years; increase of at least 1 diopter of Kmax within last 12 months for age › 25 years. Exclusion criteria: Corneal Thickness of less than 400 microns; Kmax more than 61D; previous herpetic infection; Concurrent keratitis; Severe corneal opacity; history of poor epithelial healing; Autoimmune diseases; Severe ocular surface diseases.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
K max. Timepoint: pre and post op. Method of measurement: Using pentacam imaging.;Time required for reepithelialization. Timepoint: post op, at days 1-3-5 & 7. Method of measurement: Slit lamp exam.;Uncorrected Visual acuity. Timepoint: pre and post op. Method of measurement: Physical exam.;Corrected Visual Acuity. Timepoint: pre and post op. Method of measurement: Physical exam.;Endothelial Cell Count. Timepoint: pre and post op. Method of measurement: Specular Microscopy.	—

Measure

Time frame

K max. Timepoint: pre and post op. Method of measurement: Using pentacam imaging.;Time required for reepithelialization. Timepoint: post op, at days 1-3-5 & 7. Method of measurement: Slit lamp exam.;Uncorrected Visual acuity. Timepoint: pre and post op. Method of measurement: Physical exam.;Corrected Visual Acuity. Timepoint: pre and post op. Method of measurement: Physical exam.;Endothelial Cell Count. Timepoint: pre and post op. Method of measurement: Specular Microscopy.

—

Secondary

Measure	Time frame
Sterile corneal infiltration. Timepoint: post op. Method of measurement: physical exam.;Keratitis. Timepoint: post op. Method of measurement: physical exam.;Corneal scar. Timepoint: post op. Method of measurement: physical exam.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactS.M. Salar Zaheryani

Shiraz University of Medical Sciences

smszaheryany@gmail.com+98 71 3234 1510

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026