- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936701
Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification
Age-related cataract is the main cause of impaired vision in the elderly population worldwide.
The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.
The most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.
Modifications in IOL design and material lead to a decrease in the incidence of PCO.
During the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.
The purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 2 years.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Department of Ophthalmology and Optometry of the Medical University Vienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- bilateral age-related cataract
- good overall physical constitution
Exclusion Criteria:
- previous intraocular surgery or ocular trauma
- intraocular complication like posterior capsular tear
- glaucoma
- uveitis
- corneal diseases, diabetic retinopathy and any other severe retinal -pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: acrylic 3-piece IOL
same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-XS in one eye
|
same-day bilateral cataract surgery with implantation of intraocular lens
|
Other: silicone 3-piece IOL
same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-3Ai in one eye
|
same-day bilateral cataract surgery with implantation of intraocular lens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
posterior capsular opacification (PCO)
Time Frame: 2 xears
|
subjective and objective PCO scoring
|
2 xears
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
best corrected visual acuity (BCVA)
Time Frame: 2 years
|
2 years
|
Nd:YAG rate
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK Nr: 112/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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