Cataract, Posterior Capsule Opacification
Conditions
Keywords
posterior capsule opacification, PCO, after cataract, intraocular lens
Brief summary
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 4 years.
Interventions
DEVICEHOYA iMics Y-60H
same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
OTHERB&L MI60
same-day bilateral cataract surgery with implantation of intraocular lens B&L MI60 in one eye
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| posterior capsular opacification (PCO) | 4 years | subjective and objective PCO scoring |
Secondary
| Measure | Time frame |
|---|---|
| best corrected visual acuity (BCVA) | 4 years |
| Nd:YAG rate | 4 years |
Countries
Austria
Outcome results
None listed