Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01936701

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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 2 years.

Condition or Disease	Intervention/Treatment	Phase
Posterior Capsule Opacification Cataract	Procedure: bilateral cataract surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

Comparison of the Effect of Hydrophobic Acrylic and Silicone 3-piece IOLs on Posterior Capsule Opacification

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: acrylic 3-piece IOL same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-XS in one eye	Procedure: bilateral cataract surgery 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	Procedure: bilateral cataract surgery same-day bilateral cataract surgery with implantation of intraocular lens

Arm

Intervention/Treatment

Other: acrylic 3-piece IOL

same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-XS in one eye

Procedure: bilateral cataract surgery

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

Procedure: bilateral cataract surgery

same-day bilateral cataract surgery with implantation of intraocular lens

Outcome Measures

Primary Outcome Measures

posterior capsular opacification (PCO) [2 xears]
subjective and objective PCO scoring

Secondary Outcome Measures

best corrected visual acuity (BCVA) [2 years]
Nd:YAG rate [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology and Optometry of the Medical University Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01936701

Other Study ID Numbers:

EK Nr: 112/2011

First Posted:

Sep 6, 2013

Last Update Posted:

Sep 6, 2013

Last Verified:

Sep 1, 2013

Additional relevant MeSH terms:

Cataract

Capsule Opacification

Study Results

No Results Posted as of Sep 6, 2013