Outcomes of primary iris claw intraocular lens implantation for correction aphakia in comparison with scleral fixation intraocular lens implantation during pars plana deep vitrectomy
In this prospective non-randomized clinical trial, we evaluated outcomes of primary iris claw intraocular lens implantation for correction aphakia in comparison with scleral fixation intraocular lens implantation during pars plana deep vitrectomy, in Imam Khomeini hospital of Ahwaz between September 2009 and September 2010. Intervention was performed only in one group and 12 patients who had inclusion criteria (dislocation of total crystalline lens v/s fragment of nucleus v/s IOL in vitreous after complicated cataract surgery or due to trauma and absence of capsular support) were enrolled in this study and operated simultaneously pars plana vitrectomy and IOL implantation. Patients of control group (13 patients) were selected retrospectively based on previous data. Outcomes included; uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), central corneal thickness (CCT), spherical equivalent (SE), and astigmatism were measured (preoperative and post operative) and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103116032N1
Registration date:2011-06-01, 1390/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-01, 1390/03/11
Registrant information
Name
Abbas Afkari
Name of organization / entity
Ahwaz Jondishapour University Of Medicine Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1444 1132
Email address
afkari.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapour University Of Medicine Science
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-09-16, 1389/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcomes of primary iris claw intraocular lens implantation for correction aphakia in comparison with scleral fixation intraocular lens implantation during pars plana deep vitrectomy
Public title
The evaluation of aphakic iris claw intraocular lens implantation results
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Dislocation of total crystalline lens v/s fragment of nucleus v/s IOL in vitreous after complicated cataract surgery or due to trauma, Absence of capsular support for IOL implantation in capsular bag or ciliary sulcus
Exclusion criteria: Uncontrolled glaucoma, recurrent uveitis history, severe iris damage, proliferative diabetic retinopathy, macular scar
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Ahwaz Jondishapour University Of Medicine Science
Street address
Golestan street, Aahvaz
City
Ahwaz
Postal code
6135715794
Approval date
2010-07-15, 1389/04/24
Ethics committee reference number
2192
Health conditions studied
1
Description of health condition studied
Aphakia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
uncorrected visual acuity (UCVA)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
visual acuity without correction based on snellen chart at 6 meter
2
Description
best corrected visual acuity (BCVA)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
visual acuity based on snellen chart at 6 meter,after correction.(based on subjective refraction
3
Description
central corneal thickness (CCT)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
central corneal thickness (micron) based on Pachymetry
4
Description
spherical equivalent (SE)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
spherical power (diopter) based on objective refraction.: S.E =Sphere+Cylinder/2
5
Description
astigmatism
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
cylinder power based on objective refraction
Secondary outcomes
1
Description
cystoid macular edema (complication)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
Edema in macular zone based on fundus examination.(confirmed by OCT)
2
Description
Intra ocular pressure(IOP) increase (complication)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
IOP> 22 mmHg (Based on Goldmann Tonometer)
3
Description
Retinal Detachment (complication)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
Based on fundus examination
4
Description
lens haptic displacement (complication)
Timepoint
one day preoperatively and the first day, third day, at the end of the first
Method of measurement
Based on Slit Lamp examination
Intervention groups
1
Description
The ARTISAN aphakia IOL is a polymethyl methacrylate IOL with an 8.5-mm length, and a 5.5-mm optical zone. In one group patients, initialy a standard 3-port Pars Plana vitrectomy were performed. Crystalline lens or fragment of nucleus that dropped into vitreous extracted by phacofragmentation. Dislocated IOL in vitreous extracted from limbal incision. Then acetylcholine 1% was injected to constrict the pupil and from limbal incision an Artisan IOL was inserted in
the anterior chamber. The iris was hooked between the claw-like footplates to achieve perfect IOL centration over the pupil. Finally, the incision was closed with 10–0 nylon sutures. Control group patients were selected retrospectively, from patients that undergo pars plana vitrectomy and sclera fixation Posterior Chamber IOL implantation in past.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Abbas Afkari - ophthalmology resident
Street address
Azadegan.S
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondishapour University Of Medicine Science
Full name of responsible person
Mostafa Feghhi
Street address
Golestan.S
City
Ahwaz
Grant name
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jondishapour University Of Medicine 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
Imam Khomeini Hospital
Full name of responsible person
Abbas Afkari
Position
ophthalmology resident
Other areas of specialty/work
Street address
Azadegan.S
City
Ahwaz
Postal code
Phone
+98 61 1222 8076
Fax
Email
abafkari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapour University Of Medicine Science
Full name of responsible person
Feraidoon Farrahi
Position
Assistant profesor
Other areas of specialty/work
Street address
Azadegan .S
City
Ahwaz
Postal code
6193673166
Phone
+98 61 1222 8076
Fax
Email
feraidoonfarrahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)