Eye refractive disorders are among the most common human problems basically depend on genetic disturbances and may alter with systemic diseases. The aim of this study is the evaluation of the changes of refractive disorders in morbid obese patients whom undergo bariatric surgery and loose weight. Inclusion criteria are morbid obesity candidate for bariatric surgery, (BMI > 40, or BMI > 35 + at least one underlying disorder). Exclusion criteria are ophthalmic underlying diseases or blindness binocularly. 60 patients with the above conditions will undergo ophthalmic exams, by an optometrist, before and again after the bariatric surgery in minimally invasive research center of Tehran University of Medical Sciences.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202168588N2
Registration date:2012-04-22, 1391/02/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-04-22, 1391/02/03
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Bariatric Surgery on alterations of refractive errors in patients with morbid obesity
Public title
Evaluation of Bariatric Surgery on alterations of refractive errors in patients with morbid obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients should not be blind they have to be a candidate for Bariatric Surgery؛ BMI should be 40 and over and if it is between 35 and 40؛ then patient should have an underlying risk factor.
Exclusion criteria: patients should not have any previous underlying eye diseases؛Patients who are blind.
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tehran University of Medical science
Street address
Tehran University of Medical Sciences-Corner of Ghods-Keshavarz Blvd-Tehran-Iran
City
Tehran
Postal code
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
45001
Health conditions studied
1
Description of health condition studied
Myopia
ICD-10 code
H52.5
ICD-10 code description
Disorders of accommodation
2
Description of health condition studied
Hyperopia
ICD-10 code
H52.0
ICD-10 code description
Disorders of accommodation
Primary outcomes
1
Description
Visual acuity
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Log Minimum Angle of Resolution-snellen chart
2
Description
Cover test
Timepoint
Before Surgery and 6 month afterward
Method of measurement
Prism
3
Description
Keratometry
Timepoint
Before Surgery and 6 month afterward
Method of measurement
Millimeter
4
Description
Lensometry
Timepoint
Before Surgery and 6 month afterward
Method of measurement
Diopter
5
Description
Retinoscopy
Timepoint
Before Surgery and 6 month afterward
Method of measurement
Diopter
6
Description
Ophthalmoscopy
Timepoint
Before Surgery and 6 month afterward
Method of measurement
Ophthalmoscope
Secondary outcomes
1
Description
Sex
Timepoint
Before surgery
Method of measurement
Male and Female
2
Description
BMI
Timepoint
Before surgery and 6 month afterward
Method of measurement
Weight in Kg/Squared Height in Meter
3
Description
Age
Timepoint
before surgery and 6 month afterward
Method of measurement
Year
Intervention groups
1
Description
Laparoscopic Bariatric Surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.
Full name of responsible person
Mrs.Mohadeseh Pishgah
Street address
Niyayesh Ave, Sattarkhan St., Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Terarn university of Medical science.
Full name of responsible person
Dr. Fotouhi
Street address
Corner of Ghods, Keshavarz Blvd., Tehran University of Medical Sciences, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Terarn university of Medical science.
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
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.
Full name of responsible person
Khashayar Mehidzadehkashi
Position
Last Course Student of BS in Optometry
Other areas of specialty/work
Street address
App. 3 west, No. 11, Saeedi Ave. Fereshteh St. Valieasr St.
City
Tehran
Postal code
Phone
+98 21 2264 8334
Fax
Email
amoo_khashi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.
Full name of responsible person
Dr.Abdolreza Pazouki
Position
Laparoscopy Fellowship
Other areas of specialty/work
Street address
Niyayesh Ave, Sattarkhan St., Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5448
Fax
Email
apazouki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Minimaly Invasive Surgery Research Center
Full name of responsible person
Mohadeseh pishgah-Roudsari
Position
Research and Statistic Expert
Other areas of specialty/work
Street address
Niyayesh Ave, Sattarkhan St., Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
mo.pishgah@gmail.com,research@lapsurg.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)