Protocol summary

Summary
The aim of this research is to study the effect of photorefractive keratectomy refractive surgery on posterior corneal elevation. In this research 32 eyes of 16 patients aged 15 to 50 referred to Vanak Eye Surgery Center will be recruited. Posterior corneal elevation before and 3 months after photorefractive keratectomy surgery by Pentacam will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201009273101N4
Registration date: 2010-10-07, 1389/07/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-10-07, 1389/07/15
Registrant information
Name
Mohamad Sadegh Ghasemi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 9086
Email address
m.s.ghasemi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-10-22, 1389/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
posterior corneal elevation changes after photorefractive keratectomy
Public title
posterior corneal elevation changes after photorefractive keratectomy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: candidates of photorefractive keratectomy, myopic patients, no use of rigid contact lenses 1 month and soft contact lenses 2 weeks before surgery, residence in Tehran Exclusion criteria: corneal pathology such as keratoconus, use of ocular drugs, previous ocular surgery, amblyopia, pregnancy
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of faculty of rehabilitation, Iran University of Medical Sciences
Street address
Rehabilitation college, Shahnazari St, Madar avenue, Mirdamad blvd
City
tehran
Postal code
Approval date
empty
Ethics committee reference number
233

Health conditions studied

1

Description of health condition studied
myopia
ICD-10 code
H52.1
ICD-10 code description
MYOPIA

Primary outcomes

1

Description
posterior corneal elevation
Timepoint
before and 3 months after surgery
Method of measurement
Pentacam

Secondary outcomes

empty

Intervention groups

1

Description
photorefractive keratectomy refractive surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Vanak Eye Surgery center
Full name of responsible person
Dr Nader Nasiri
Street address
Vanak square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr M. Moradi Lakeh
Street address
Iran University of Medical Sciences-Hemmat expway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Iran University of Medical Sciences
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
Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Dr Mohamad Sadegh Ghasemi
Position
Assistant Professor, PhD
Other areas of specialty/work
Street address
Rehabilitation college,Shahnazari St,Madar Ave,Mirdamad blvd
City
Tehran
Postal code
Phone
+98 21 2222 9086
Fax
Email
m.s.ghasemi@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of RehabilitationIran University of Medical Sciences
Full name of responsible person
Vahid Damanpak
Position
Master of science in optometry
Other areas of specialty/work
Street address
Rehabilitation college, Shahnazari St, Madar Square, Mirdamad blvd
City
Tehran
Postal code
Phone
+98 21 2222 9086
Fax
Email
vahiddamanpak@gmail.com
Web page address

Person responsible for updating data

Contact

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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