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Protocol summary
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, 6 and 12 month after surgery), contrast sensitivity testing, corneal biomechanic factors, aberrometry, IOP measurement and slit lamp examination.
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.
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, 6 and 12 month after surgery), contrast sensitivity testing, corneal biomechanic factors, aberrometry, IOP measurement and slit lamp examination. Refraction and IOP measurement will also be performed 2 months postoperatively.
بیماران کاندید جراحی پی آر کی که واجد شرایط ورود به مطالعه هستند، در بیمارستان چشم پزشکی نور تحت عمل پی آرکی با میتومایسین 02/0 درصد قرار خواهند گرفت. پس از عمل، به مدت 3 ماه با استروئید یا دارو نما تحت درمان قرار می گیرند. آزمایشات زیر قبل و 1، 3، 6 و 12 ماه پس از عمل انجام خواهد شد.
اندازه گیری کدورت قرنیه، حدت بینایی بدون تصحیح، رفرکشن و حدت بینایی با بهترین تصحیح، سایکلورفرکشن (سایکلورفرکشن قبل از عمل و ماه 6 و 12 بعد از عمل)، اندازه گیری حساسیت کنتراست، معاینات کامل اسلیت لمپی و اندازه گیری فشار چشم، اندازه گیری فاکتور های بیومکانیک قرنیه و ابرومتری.
بیماران کاندید جراحی پی آر کی که واجد شرایط ورود به مطالعه هستند، در بیمارستان چشم پزشکی نور تحت عمل پی آرکی با میتومایسین 02/0 درصد قرار خواهند گرفت. پس از عمل، به مدت 3 ماه با استروئید یا دارو نما تحت درمان قرار می گیرند. آزمایشات زیر قبل و 1، 3، 6 و 12 ماه پس از عمل انجام خواهد شد.
اندازه گیری کدورت قرنیه، حدت بینایی بدون تصحیح، رفرکشن و حدت بینایی با بهترین تصحیح، سایکلورفرکشن (سایکلورفرکشن قبل از عمل و 12 ماه بعد از عمل)، اندازه گیری حساسیت کنتراست، معاینات کامل اسلیت لمپی و اندازه گیری فشار چشم و ابرومتری.
اندازه گیری فشار چشم و رفرکشن در ماه دوم نیز انجام خواهد شد
بیماران کاندید جراحی پی آر کی که واجد شرایط ورود به مطالعه هستند، در بیمارستان چشم پزشکی نور تحت عمل پی آرکی با میتومایسین 02/0 درصد قرار خواهند گرفت. پس از عمل، به مدت 3 ماه با استروئید یا دارو نما تحت درمان قرار می گیرند. آزمایشات زیر قبل و 1، 3، 6 و 12 ماه پس از عمل انجام خواهد شد. اندازه گیری کدورت قرنیه، حدت بینایی بدون تصحیح، رفرکشن و حدت بینایی با بهترین تصحیح، سایکلورفرکشن (سایکلورفرکشن قبل از عمل و 12 ماه 6 و 12 بعد از عمل)، اندازه گیری حساسیت کنتراست، معاینات کامل اسلیت لمپی و اندازه گیری فشار چشم، و ابرومتری. اندازه گیری فاکتور های بیومکانیک قرنیهفشار چشم و ابرومتری.رفرکشن در ماه دوم نیز انجام خواهد شد
Primary outcomes
#1
Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery
Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery
Before photorefractive keratectomy, 11,2, 3, 6 and 12 months after surgery
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،3، 6 و 12 ماه پس از عمل
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،2، 3، 6 و 12 ماه پس از عمل
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،2، 3، 6 و 12 ماه پس از عمل
Secondary outcomes
#1
Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery
Before photorefractive keratectomy, 1,3, 6 and 12 months after surgery
Before photorefractive keratectomy, 1, 31,3, 6 and 12 months after surgery
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،3، 6 و 12 ماه پس از عمل
قبل ازعمل فتورفرکتیو کراتکتومی ، 1، 3، 6 و 12 ماه پس از عمل
قبل ازعمل فتورفرکتیو کراتکتومی ، 1،3، 6 و 12 ماه پس از عمل
#2
Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery
Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery
Before photorefractive keratectomy, 11,2, 3, 6 and 12 months after surgery
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،3، 6 و 12 ماه پس از عمل
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،2، 3، 6 و 12 ماه پس از عمل
قبل ازعمل فتورفرکتیو کراتکتومی ، 1 ،2، 3، 6 و 12 ماه پس از عمل
2. Intervention group: Participants who will receive topical steroid after PRK for 3 months. A one week of Betamethasone 0.1% and 7 weeks of tapering Fluorometholone 0.1% (FML).
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).
2. Intervention group: Participants who will receive topical steroid after PRK for 32 months. A one week of Betamethasone 0.1% and 7 weeks of tapering Fluorometholone 0.1% (FML).
#2
3. Intervention group: Participants who will receive topical steroid after PRK for 3 months. A one week of Betamethasone 0.1% and 3 weeks of tapering Fluorometholone 0.1% (FML).
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).
3. Intervention group: Participants who will receive topical steroid after PRK for 31 months. A one week of Betamethasone 0.1% and 3 weeks of tapering Fluorometholone 0.1% (FML).
3- گروه مداخله: افرادی که بعد از عمل پی آرکی به مدت 4 ماه استروئید موضعی دریافت می کنند. هفته ی اول بتامتازون 0/1 درصد و 3 هفته ی بعد فلورمتولون 0/1 درصد که به تدریج کم و قطع خواهد شد.
3- گروه مداخله: افرادی که بعد از عمل پی آرکی به مدت 1 ماه استروئید موضعی دریافت می کنند. هفته ی اول بتامتازون 0/1 درصد و 3 هفته ی بعد فلورمتولون 0/1 درصد که به تدریج کم و قطع خواهد شد.
3- گروه مداخله: افرادی که بعد از عمل پی آرکی به مدت 41 ماه استروئید موضعی دریافت می کنند. هفته ی اول بتامتازون 0/1 درصد و 3 هفته ی بعد فلورمتولون 0/1 درصد که به تدریج کم و قطع خواهد شد.
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
Name
Mojgan Pakbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8240 1675
Email address
m_pakbin@razi.tums.ac.ir
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
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
University Central Building,Ghods St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417733161
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
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Eye Hospital
Full name of responsible person
Mojgan Pakbin
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8240 1675
Fax
Email
m_pakbin@razi.tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Noor Eye hospital
Full name of responsible person
Dr. Hassan Ghazizadeh Hashemi
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Email
research@norc.ac.ir
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
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Pakbin
Position
PhD student in ophthalmic research
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653131
Phone
+98 21 8240 1675
Email
m_pakbin@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hassan Hashemi
Position
Professor, Ophthalmology Department, Tehran University of Medical Sciences, Tehran, Iran
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653131
Phone
+98 21 8240 1675
Email
research@norc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Pakbin
Position
PhD student in ophthalmic research
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653131
Phone
+98 21 8240 1675
Email
m_pakbin@razi.tums.ac.ir
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