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Comparison of of two pharmaceutical products of Riboflavin for keratoconus

Comparison of clinical results of two pharmaceutical products of Riboflavin in corneal collagen Cross-Linking for keratoconus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201212034333N2
Enrollment
60
Registered
2014-02-25
Start date
2014-04-06
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. Keratoconus

Interventions

Intervention 1: Interventional group: After local anaesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will
Treatment - Drugs
Interventional group: After local anaesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will be left untouch
Control group: After local anesthesia, the central 7 mm corneal epithelium will be manually removed as 3 or 4 vertical strips about 2 mm wide and 1-mm strips of epithelium will be left untouched in be

Sponsors

Noor Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 35 Years

Inclusion criteria

Inclusion criteria: The inclusion criterion is the clinical diagnosis of progressive keratoconus with paraclinical confirmation. The criteria of progressive keratoconus is an increase of at least 1D in maximum keratometry, astigmatism, or manifest refraction, or loss of 2 best corrected visual acuity (BCVA) lines or more in the past 12 months. Patients aged 15-35 years old with keratometry less than 55D and a central corneal thickness less than 400 µ will be selected for the study. Patients with other ocular diseases or a history of ocular surgery will be excluded from the study. Participants discontinue the use of the hard and soft contact lens 3 weeks and 3 days prior to the surgery, respectively.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Visual acuity. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: Snellen chart.;Refraction. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: retinoscope.;Corneal topography. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: pentacam.;Corneal rigidity. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: ORA.;Endothelial cell count. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: non-contact specular microscope.

Secondary

MeasureTime frame
Corneal Haze. Timepoint: 1, 3, 6, and 12 months after surgery. Method of measurement: Opthalmic examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoheila Asgari

Noor Ophthalmology Research Center

soheilaasgari@gmail.com+98 21 8865 1515

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 18, 2026