Steroid after PRK

Short versus long term topical steroid effect on corneal haze incidence after photorefractive keratectomy with mitomycin-C

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180428039441N1

Enrollment

222

Registered

2018-08-27

Start date

2018-09-23

Completion date

Unknown

Last updated

2019-01-29

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

Conditions

Corneal haze after photorefractive keratectomy. Other corneal scars and opacities

Interventions

Intervention 1: 1. Control group: Participants who will receive topical steroid after PRK for 3 months. A one week of Betamethasone 0.1% and 11 weeks of tapering Fluorometholone 0.1% (FML). Interventi

Eligibility

Sex/Gender

All

Age

21 Years to 40 Years

Inclusion criteria

Inclusion criteria: PRK candidates in following criteria Age: 21-40 years Spherical Equivalent (SE): 0 to -6.00 Diopter Astigmatism: equal to -2.00 D or less Best corrected visual acuity (BCVA): 20/25 or better Patient's desire to participate in study and post-operative follow-ups Discontinuing soft contact lenses using 1 week and hard contact lenses 3 weeks before first examination Steady refractive errors (change < 0.5 dioptre) during a year before photorefractive keratectomy

Exclusion criteria

Exclusion criteria: Pregnancy, breastfeeding or pregnancy planning during the study period Using corticosteroid medications (topical or systemic) that interfere with the recovery process Systemic diseases such as diabetes or Thyroid disease Glaucoma or intraocular pressure greater than 21 mm Hg Keratoconus, any corneal irregularity or opacity Untreated Blepharitis or MGD (meibomian gland dysfunction) Ocular surgery history

Design outcomes

Primary

Measure	Time frame
Corneal haze score. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Slit lamp biomicroscopy (BD 900, Haag-Streit AG, Koeniz, Switzerland.;Corneal densitometry. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: Pentacam (Oculus Optikgeräte GmbH, Wetzlar, Germany).	—

Secondary

Measure	Time frame
Myopic regression. Timepoint: Before photorefractive keratectomy, 1,3, 6 and 12 months after surgery. Method of measurement: Topcon auto-refractometer (Topcon KR 8000, Topcon Corporation Tokyo, Japan)- Trial frame- NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).;Contrast sensitivity. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: CSV1000 contrast sensitivity chart (VectorVision, Dayton, OH).;Intraocular pressure. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Applanation Tonometer- Slit lamp biomicroscope (BD 900, Haag-Streit AG, Koeniz, Switzerland).;Corneal aberrations. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: Pentacam.;Unncorrected visual acuity. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).;Best corrected visual acuity. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Trial frame- NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).	—

Measure

Time frame

Myopic regression. Timepoint: Before photorefractive keratectomy, 1,3, 6 and 12 months after surgery. Method of measurement: Topcon auto-refractometer (Topcon KR 8000, Topcon Corporation Tokyo, Japan)- Trial frame- NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).;Contrast sensitivity. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: CSV1000 contrast sensitivity chart (VectorVision, Dayton, OH).;Intraocular pressure. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Applanation Tonometer- Slit lamp biomicroscope (BD 900, Haag-Streit AG, Koeniz, Switzerland).;Corneal aberrations. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: Pentacam.;Unncorrected visual acuity. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).;Best corrected visual acuity. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Trial frame- NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojgan Pakbin

Tehran University of Medical Sciences

m_pakbin@razi.tums.ac.ir+98 21 8240 1675

Outcome results

None listed

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