Comparison of Clinical Outcomes After Cataract Surgery With and Without Capsular Tension Ring

NCT ID: NCT02183831

Last Updated: 2014-07-08

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

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-06-30

Brief Summary

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This study was set up to identify clinical outcomes including a refractive shift or change in IOL calculation accuracy and optical quality after Ophtec® capsular tension ring in the eyes without zonular instability.

Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Capsular tension ring non insertion group

The patients who had same cataract surgery procedure without CTR insertion

No interventions assigned to this group

Capsular tension ring insertion group

The patients who underwent capsular tension ring insertion just before IOL implantation during cataract surgery

Insertion of the capsular tension ring

Intervention Type DEVICE

Interventions

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Insertion of the capsular tension ring

Intervention Type DEVICE

Other Intervention Names

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a pre-loaded CTR in single use injector was inserted just before IOL implantation during cataract surgery

Eligibility Criteria

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Inclusion Criteria

1. age between 40 and 79 years
2. no history of eye surgery or glaucoma
3. a transparent central cornea
4. pupil dilation at the preoperative examination of at least 6.0 mm
5. absence of biomicroscopic signs of pseudoexfoliation
6. normal fundus examination

Exclusion Criteria

1. presence of ocular disease that might affect the visual outcome (e.g., color vision disturbance, chronic uveitis)
2. presence of ocular disease that might affect contrast sensitivity function (e.g., glaucoma, maculopathy, high myopia)
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1-2014-0010

Identifier Type: -

Identifier Source: org_study_id

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