Influence of Two Different Preloaded Intraocular Lens (IOLs) on Posterior Capsule Opacification

NCT ID: NCT00673803

Last Updated: 2010-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-06-30

Brief Summary

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Studies showed that a sharp posterior optic edge of an intraocular lens (IOL) inhibits migration of lens epithelial cells in between posterior capsule and optic of the IOL and therefore reduces the rate of posterior capsule opacification (PCO). In present time most IOLs implanted have a sharp posterior optic edge. Due to differences in IOL production different IOLs have different rates of PCO.

Progression in cataract surgery technique allow phacoemulsification through micro-incisions. Therefore there is need for IOLs that can be implanted through incisions of about 2.5 mm.

This study investigates the effect of two different hydrophobic acrylic IOLs with a sharp posterior optic edge on the rate of PCO after implantation through a micro-incision. The results will be compared intraindividually.

Detailed Description

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prospective, randomized, bilateral study with intraindividual comparison, implantation of a Polylens Y10 IOL in one eye and implantation of a Polylens Y30 in the contralateral eye.

PCO rate will be detected at 1 year and 2 years.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

cataract surgery, implantation of a Polylens Y10

Group Type OTHER

cataract surgery

Intervention Type PROCEDURE

cataract surgery with implantation of an IOL

B

cataract surgery, implantation of a Polylens Y30

Group Type OTHER

cataract surgery

Intervention Type PROCEDURE

cataract surgery with implantation of an IOL

Interventions

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cataract surgery

cataract surgery with implantation of an IOL

Intervention Type PROCEDURE

Other Intervention Names

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Polylens Y30 IOL, Polytech, Germany Polylens Y10 IOL, Polytech, Germany

Eligibility Criteria

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Inclusion Criteria

* bilateral age-related cataract
* age 55 to 80 years
* expected postoperative visual acuity of at least 0.5

Exclusion Criteria

* amblyopia
* corneal scars
* diabetes
* pseudoexfoliation-syndrome
* earlier ocular surgeries or laser treatments
* intraocular tumors
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Hietzing

OTHER

Sponsor Role lead

Responsible Party

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Hietzing Hospital, Vienna, Austria

Principal Investigators

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Nadja Karnik, MD

Role: STUDY_CHAIR

Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

Locations

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Department of Ophthalmology, Hietzing Hospital

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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preloaded 2008

Identifier Type: -

Identifier Source: org_study_id

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