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Comparison of Loteprednol 0.5% with Fluorometholone 0.1% after Myopic Photorefractive Keratectomy (PRK)

Comparison of Loteprednol 0.5% with Fluorometholone 0.1% after Myopic Photorefractive Keratectomy (PRK)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016081629386N1
Enrollment
62
Registered
2016-10-09
Start date
2016-06-11
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

intraocular pressure. Glaucoma secondary to drugs

Interventions

Intervention 1: control group: Another eye of each patient was received Flourometholone 0.1% four times a day for the first month, then three times a day for the second month and two times a day for t
Treatment - Drugs
control group: Another eye of each patient was received Flourometholone 0.1% four times a day for the first month, then three times a day for the second month and two times a day for the third month
intervention group: Each patient was randomly allocated to receive loteprednol 0.5% in one eye four times a day for the first month, then three times a day for the second month and two times a day

Sponsors

Vice Chancellor Of Research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age more than 18 years; stable refraction for at least 12 month with myopia between -8.0 to -1.0 Diopters and astigmatism less than 4.0 Diopters; normal eye examination (except refractive error); corrected distance visual acuity (CDVA) of 20/20; no history of systemic or autoimmune disease or receiving immunosuppressive treatment; neither pregnant nor breast feeder; using no topical ophthalmic medication; have no contraindication for PRK. Exclusion criteria: Patients were unable to return for follow-up or needed to increase drug dosage for any reason; patients who did not follow the instructions correctly; patients with anisometropia (more than 1 diopter) or significant pre-operative central corneal thickness difference between two eyes (more than 20 µm); those who received MMC just in one eye; patients with postoperative complications like keratitis.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Intraocular pressure post photorefractive keratectomy. Timepoint: pre operation and 1,2,3 month post op. Method of measurement: Intraocular pressure was measured over central cornea by Goldmann applanation tonometer.

Secondary

MeasureTime frame
Visual acuity. Timepoint: pre operative and 1,2,3 month post operatively. Method of measurement: Snellen chart.;Corneal haze. Timepoint: 3 month post operatively. Method of measurement: slit lamp examination.;Ocular surface side effects related to topical drugs including eye redness and eye discomfort. Timepoint: 3 month post operatively. Method of measurement: question.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahba Fekri

Shahid Beheshti University of Medical Sciences

fekri22sahba@yahoo.com; fekri22sahba@sbmu.ac.ir+98 21 2277 0957

Outcome results

None listed

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