Protocol summary
-
Study aim
-
To compare the effect of short versus long term steroids on corneal haze incidence after photorefractive keratectomy with mitomycin-C
-
Design
-
Randomized clinical trial with concealed allocation, 3 parallel group and double blinded
-
Settings and conduct
-
In Noor Eye hospital, a total of 222 PRK candidates who meet the study criteria will undergo PRK surgery with MMC (0.02%) and randomly assigned to 3 groups for post-operative care (topical steroid administration). The following examinations will perform before the surgery, 1, 3, 6 and 12 months after PRK:
Corneal score measurement, uncorrected and best corrected visual acuity values, refraction, cyclorefraction (before and 12 month after surgery), contrast sensitivity testing, aberrometry, IOP measurement and slit lamp examination.
Refraction and IOP measurement will also be performed 2 months postoperatively.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
PRK candidates (21-40 years), with refractive spherical equivalent (SE) ≤ -6, astigmatism ≤ -2, best corrected visual acuity (BCVA) ≥ 20/25 and Steady refractive errors during a year before surgery
Exclusion criteria:
Pregnancy, breastfeeding, using corticosteroid medications, systemic diseases, Glaucoma, any corneal irregularity or opacity and ocular surgery history
-
Intervention groups
-
Administration of topical steroid after PRK:
Betamethasone 0.1% for the first week Post-operative and after that Fluorometholone 0.1% (FML) in following order:
A. FML (3 weeks) + placebo (2 months)
B. FML (7 weeks) + placebo (1 month)
C. FML (11 weeks)
-
Main outcome variables
-
Corneal haze score; corneal densitometry
General information
-
Reason for update
-
-
Acronym
-
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180428039441N1
Registration date:
2018-08-27, 1397/06/05
Registration timing:
prospective
Last update:
2019-01-07, 1397/10/17
Update count:
1
-
Registration date
-
2018-08-27, 1397/06/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-09-23, 1397/07/01
-
Expected recruitment end date
-
2020-09-22, 1399/07/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Short versus long term topical steroid effect on corneal haze incidence after photorefractive keratectomy with mitomycin-C
-
Public title
-
Steroid after PRK
-
Purpose
-
Prevention
-
Inclusion/Exclusion 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:
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
-
Age
-
From 21 years old to 40 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
222
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization will be done using permuted-block randomization method. In addition to balancing the number of people between the three groups, this method It can prevent the prediction of intervention sequence. Blocks random sequence will be provided by STATA software. In order to maintenance of allocation concealment, full report will be published after completion of the study.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Patients will be unaware of which group (intervention or placebo) they are in. Also, those who perform the tests (optometrists and the clinical ophthalmologist responsible for corneal opacity diagnosis) will also be unaware of which group (intervention or placebo) is evaluating.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2618-07-18, 1997/04/27
-
Ethics committee reference number
-
IR.TUMS.FARABIH.REC.1397.010
Health conditions studied
1
-
Description of health condition studied
-
Corneal haze after photorefractive keratectomy
-
ICD-10 code
-
H17.8
-
ICD-10 code description
-
Other corneal scars and opacities
Primary outcomes
1
-
Description
-
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
2
-
Description
-
Corneal densitometry
-
Timepoint
-
Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery
-
Method of measurement
-
Pentacam (Oculus Optikgeräte GmbH, Wetzlar, Germany)
Secondary outcomes
1
-
Description
-
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)
2
-
Description
-
Contrast sensitivity
-
Timepoint
-
Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery
-
Method of measurement
-
CSV1000 contrast sensitivity chart (VectorVision, Dayton, OH)
3
-
Description
-
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)
4
-
Description
-
Corneal aberrations
-
Timepoint
-
Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery
-
Method of measurement
-
Pentacam
5
-
Description
-
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)
6
-
Description
-
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)
Intervention groups
1
-
Description
-
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).
-
Category
-
Treatment - Drugs
2
-
Description
-
2. Intervention group: Participants who will receive topical steroid after PRK for 2 months. A one week of Betamethasone 0.1% and 7 weeks of tapering Fluorometholone 0.1% (FML).
-
Category
-
Treatment - Drugs
3
-
Description
-
3. Intervention group: Participants who will receive topical steroid after PRK for 1 months. A one week of Betamethasone 0.1% and 3 weeks of tapering Fluorometholone 0.1% (FML).
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Noor Eye hospital
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Other
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
Per request, we will decide about the dissemination of the data.
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable