NCT01786356

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 4 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

4.8 years

First QC Date

February 5, 2013

Last Update Submit

February 5, 2013

Conditions

Posterior Capsule OpacificationCataract

Keywords

posterior capsule opacificationPCOafter cataractintraocular lens

Outcome Measures

Primary Outcomes (1)

  • posterior capsular opacification (PCO)

    subjective and objective PCO scoring

    4 years

Secondary Outcomes (2)

  • best corrected visual acuity (BCVA)

    4 years

  • Nd:YAG rate

    4 years

Study Arms (2)

HOYA iMics Y-60H

OTHER

eyes with implanted intraocular lens HOYA iMics Y-60H

Device: HOYA iMics Y-60H

B&L MI60

OTHER

eyes with implanted intraocular lens B\&L MI60

Other: B&L MI60

Interventions

HOYA iMics Y-60HDEVICE

same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye

HOYA iMics Y-60H
B&L MI60OTHER

same-day bilateral cataract surgery with implantation of intraocular lens B\&L MI60 in one eye

B&L MI60

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

CataractCapsule Opacification

Condition Hierarchy (Ancestors)

Lens DiseasesEye 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

February 5, 2013

First Posted

February 7, 2013

Study Start

March 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

AU(1)