NCT00673803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 17, 2010

Status Verified

December 1, 2008

Enrollment Period

7 months

First QC Date

May 6, 2008

Last Update Submit

August 16, 2010

Conditions

Cataract

Keywords

posterior capsule opacificationmicro incisionsharp optic edge

Outcome Measures

Primary Outcomes (1)

  • PCO rate

    2 years after surgery

Study Arms (2)

A

OTHER

cataract surgery, implantation of a Polylens Y10

Procedure: cataract surgery

B

OTHER

cataract surgery, implantation of a Polylens Y30

Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

cataract surgery with implantation of an IOL

Also known as: Polylens Y30 IOL, Polytech, Germany, Polylens Y10 IOL, Polytech, Germany
AB

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • amblyopia
  • corneal scars
  • diabetes
  • pseudoexfoliation-syndrome
  • earlier ocular surgeries or laser treatments
  • intraocular tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Hietzing Hospital

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Nadja Karnik, MD

    Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2009

Study Completion

June 1, 2010

Last Updated

August 17, 2010

Record last verified: 2008-12

Locations

AU(1)