The aim of this study is to evaluate the outcome of Phakic posterior chamber intraocular lens implantation in patients with keratoconus. 20 keratoconus patients referring to Nikoukari hospital, Tabriz, Iran, will be involved in a unicentral clinical trial and chosen to undergo a Collamer ICL Phakic posterior chamber lens implantation surgery. The corrected and uncorrected visual acuity together with the refractive error would be measured before surgery and 6 months after surgery to be compared to see if this operation might be as a treatment option for such patients. The key inclusion criteria are to have keratoconus; more than 4 diopter myopia and intolerance to contact lenses while the key exclusion criteria would be to have history of cataract; prior intraocular surgery; retinopathy; glaucoma; retinal detachment and other surgical interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012063010143N1
Registration date:2012-07-09, 1391/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-09, 1391/04/19
Registrant information
Name
Tahmineh Aryan
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3655 8124
Email address
afshin_lotfi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2012-11-10, 1391/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome of Phakic posterior chamber intraocular lens implantation in patients with keratoconus
Public title
Intraocular lens implantation in keratoconus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having keratoconus; more than 4 diopter myopia; clarity of cornea; anterior chamber depth more than 3mm; number of endothelial cells more than 2000; intolerance to contact lenses.
Exclusion criteria: history of cataract; prior intraocular surgery; retinopathy; glaucoma; retinal detachment and other surgical interventions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Tabriz University of Medical Sciences
Street address
Vice cancellor for research, Tabriz University of Medical Siences, Daneshgah square
City
Tabriz
Postal code
Approval date
2012-05-04, 1391/02/15
Ethics committee reference number
9152
Health conditions studied
1
Description of health condition studied
Keratoconus
ICD-10 code
H18.6
ICD-10 code description
Keratoconus
Primary outcomes
1
Description
Uncorrected visuak acuity
Timepoint
Before and 6 months after surgery
Method of measurement
Using LogMAR
2
Description
Corrected visual acuity
Timepoint
Before and 6 months after surgery
Method of measurement
Using LogMAR
3
Description
Refractive error
Timepoint
Before and 6 months after surgery
Method of measurement
Using Spherical equivalent
Secondary outcomes
empty
Intervention groups
1
Description
All individuals involved in this study will undergo a Collamer ICL Phakic posterior chamber lens implantation surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikoukari hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Siences, Daneshgah square
City
Tabriza
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Neusha
Position
MD, Ophthalmology resident
Other areas of specialty/work
Street address
Nikoukari hospital, Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
mreza63neusha@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Lotfi
Position
Assistant Professor, Ophthalmologist
Other areas of specialty/work
Street address
Nikoukari hospital, Abbsi avenue
City
Tabriz
Postal code
Phone
+98 41 1657 7330
Fax
Email
afshin_lotfi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Univesity of Medical Sciences
Full name of responsible person
Mohammadreza Neusha
Position
MD, Ophthalmology resident
Other areas of specialty/work
Street address
Nikoukari hospital, Abbasi avenue
City
Tabriz
Postal code
Phone
Fax
Email
mreza63neusha@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)