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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

cataract surgery

About this trial

This is an interventional treatment trial for Cataract focused on measuring posterior capsule opacification, micro incision, sharp optic edge

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Ophthalmology, Hietzing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm Description

cataract surgery, implantation of a Polylens Y10

cataract surgery, implantation of a Polylens Y30

Outcomes

Primary Outcome Measures

PCO rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00673803

First Posted

May 6, 2008

Last Updated

August 16, 2010

Sponsor

Hospital Hietzing

1. Study Identification

Unique Protocol Identification Number

NCT00673803

Brief Title

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

Official Title

Influence of Two Sharp-edged Hydrophobic Acrylic Micro-incision-IOLs on Posterior Capsule Opacification. A Randomized, Double-masked Study With Intraindividual Comparison.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Hietzing

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

posterior capsule opacification, micro incision, sharp optic edge

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

cataract surgery, implantation of a Polylens Y10

Arm Title

Arm Type

Other

Arm Description

cataract surgery, implantation of a Polylens Y30

Intervention Type

Procedure

Intervention Name(s)

cataract surgery

Other Intervention Name(s)

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

Intervention Description

cataract surgery with implantation of an IOL

Primary Outcome Measure Information:

Title

PCO rate

Time Frame

2 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadja Karnik, MD

Organizational Affiliation

Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Ophthalmology, Hietzing Hospital

City

Vienna

ZIP/Postal Code

1130

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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