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

NCT01936701 | Completed

• 1 other identifier: EK Nr: 112/2011
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Capsule Opacification; Cataract

Outcome Measures

Primary Outcomes (1)

• posterior capsular opacification (PCO)

  subjective and objective PCO scoring

  2 xears

Secondary Outcomes (2)

• best corrected visual acuity (BCVA)

  2 years

• Nd:YAG rate

  2 years

Study Arms (2)

acrylic 3-piece IOL

OTHER

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

Procedure: bilateral cataract surgery

silicone 3-piece IOL

OTHER

same-day bilateral cataract surgery with implantation of intraocular lens Domilens KS-3Ai in one eye

Procedure: bilateral cataract surgery

Interventions

bilateral cataract surgery PROCEDURE

same-day bilateral cataract surgery with implantation of intraocular lens

acrylic 3-piece IOL; silicone 3-piece IOL

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral age-related cataract
• good overall physical constitution

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao.Univ.-Prof. Dr.med.univ.

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

AU (1)