Protocol summary

Summary
The purpose of this study is to evaluate the effect of Mytomycin-C on the Corneal Endothelium during Excimer Laser Surface Ablation. This clinical trial was unicenter, prospective, interventional, masked study, conducted at Basir eye center, Tehran, Iran. Bilateral myopic patients scheduled to have surface ablation procedure were recruited. The inclusion criteria was ablation depths less than 65 µm. Patients with unstable refraction, suspicious of keratoconus, excessive dry eyes, impaired wound healing processes, lenticular changes, corneal dystrophy, history of ocular surgery, anterior or posterior uveitis, glaucoma, retinal diseases, and also ablation depths of 65 µm or more were excluded. Sample size is 100 patients. One eye was randomly assigned to receive intraoperative topical MMC, and Balanced Salt Solution (BSS) was used in the fellow eye of the same patient. The outcome measure of the study is endothelial cell density 3 and 6 months post surgical.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110087741N1
Registration date: 2012-01-08, 1390/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Mina Almasi
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 0003
Email address
almasi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Basir Eye Center
Expected recruitment start date
2010-11-06, 1389/08/15
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using mitomycin-c during Laser Assisted Sub-Epithelial Keratectomy on the corneal endothelium: A Clinical Trial.
Public title
Effect of Mytomycin-C on the Corneal Endothelium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Myopic patients with ablation depths less than 65 µm. Exclusion criteria: Patients with unstable refraction, suspicion of keratoconus, excessive dry eyes, impaired wound healing processes, lenticular changes, corneal dystrophy, history of ocular surgery, anterior or posterior uveitis, glaucoma, and retinal diseases.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Pursina avenue, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2008-08-25, 1387/06/04
Ethics committee reference number
87-04-61-7585

Health conditions studied

1

Description of health condition studied
myopia
ICD-10 code
H53, H54
ICD-10 code description
Visual disturbances and blindness

Primary outcomes

1

Description
Endothelial cell density
Timepoint
pre surgical and 3 and 6 months post surgical
Method of measurement
specular microscopy

Secondary outcomes

empty

Intervention groups

1

Description
One eye was randomly assigned to receive intraoperative topical MMC, and Balanced Salt Solution (BSS) was used in control group. In each subject, MMC 0.02% (0.2 mg/ml) solution was applied on the ablated zone of the selected eye. The 7 mm round cellulose sponge soaked in MMC was kept in the target area for 5 seconds. Then the sponge was picked up and residual MMC was thoroughly irrigated with BSS.
Category
Treatment - Drugs

2

Description
In control group BSS was applied on the ablated zone.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Basir eye center
Full name of responsible person
Dr Ramezan zade
Street address
North Jamalzade
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Basir eye center
Full name of responsible person
Dr Ahmad Shojaee
Street address
Number 359, alley Sheibani, before Fatemi Avenue, North Jamalzade street, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Basir eye center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Aslani
Position
MD.
Other areas of specialty/work
Street address
North Jamalzade
City
Tehran
Postal code
Phone
+98 21 6659 2626
Fax
Email
md_aslani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Aslani
Position
MD
Other areas of specialty/work
Street address
North Jamalzade
City
Tehran
Postal code
Phone
+98 21 6659 2626
Fax
Email
md_aslani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Almasi
Position
MD.
Other areas of specialty/work
Street address
N. Jamalzadeh
City
Tehran
Postal code
Phone
Fax
Email
miina.almasii@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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