Objective:Comparison between effects of single clear corneal incision and paired opposite clear corneal incisions on corneal astigmatism and aberrations after cataract surgery based on wavefront analysis in patients with astigmatism
Key inclusion and exclusion criteria: patients requiring cataract surgery, which is equal to or greater than 1.5 diopters of astigmatism Preoperative have entered into this study. Any patients with corneal disease such as corneal scar,pterygium, history of corneal surgery for any reason and peri operative complications should be excluded.
Study population: patients with cataract referred to Feiz Hospital, Isfahan, and astigmatism are more than 1.5 diopters.
Sample size: 50 patients (25 patients in each group)
Intervention Study: Patients are randomley assigned in two groups: single clear corneal incision and paired opposite clear corneal incisions.standard cataract surgery with these incisions will be done.
Time:MARCH 2011-JAN 2013; Feiz hospital,Isfahan,Iran
Primary outcome:keratometric astigmatism and optical aberrations
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031712833N1
Registration date:2013-04-21, 1392/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Nima Koosha
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1776 8475
Email address
koosha@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Corneal astigmatism & wavefront aberration changes after cataract surgery: single clear corneal incision versus paired opposite clear corneal incisions
Public title
Effect of corneal incision in cataract surgery on astigmatism and optical aberrations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with cataract ; Corneal astigmatism greater than 1.5 diopter
Exclusion:Any other corneal pathology; Corneal scar; Pteregium; History of previos corneal surgery; Peri operative complication.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Isfahan University Of Medical Sciences
Street address
Daneshgah Ave
City
Isfahan
Postal code
Approval date
2011-10-19, 1390/07/27
Ethics committee reference number
391296
Health conditions studied
1
Description of health condition studied
corneal astigmatism and aberrations
ICD-10 code
H 52.2,
ICD-10 code description
Disorders of ocular muscles, binocular movement, accommodation and refraction,
Primary outcomes
1
Description
Keratometric astigmatism
Timepoint
Preoperation and 3monthes postoperation
Method of measurement
Keratometery
2
Description
Optical aberrations
Timepoint
Preoperation and 3 months post operation
Method of measurement
Wavefront
Secondary outcomes
empty
Intervention groups
1
Description
Control group:Single clear corneal incision on steep meridian
Category
Treatment - Surgery
2
Description
Intervention group:Paired opposite clear corneal incisions on steep meridian
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Dr.Hasan Razmjoo
Street address
Qhods Sq, Modarres St
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr Hasan Razmjoo
Street address
Daneshgah Ave
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Nima Koosha
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Num 118, Shahid soleymani st. Farhang st ,Simin st
City
Isfahan
Postal code
8177784311
Phone
+98 31 1776 8475
Fax
Email
koosha@resident.mui.ac.ir n_koosha@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Nima Koosha
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Num 118, Shahid soleymani st, Farhang st, Simin st,
City
Isfahan
Postal code
8177784311
Phone
+98 31 1776 8475
Fax
Email
koosha@resident.mui.ac.irn_koosha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Nima Koosha
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Num 118, Shahid Soleymani st, Farhang st, Simin st
City
Isfahan
Postal code
8177784311
Phone
+98 31 1776 8475
Fax
Email
koosha@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)