Effect of CTR: Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome

Sponsor
University of Occupational and Environmental Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT01455168
Collaborator
(none)
30
1
109
0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the efficacy of a capsular tension ring (CTR) in preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (XFS) with no zonular weakness. The eyes with XFS undergo phacoemulsification and aspiration (PEA) with an intraocular lens (IOL) implantation. All operations are performed by a single surgeon. No eyes with either ectopia lentis or phacodonesis are included. There are three groups; CTR is not used in group A, CTR is simply implanted in group B, and CTR is implanted and closed by tying both eyelets in group C. The areas of continuous curvilinear capsulorhexis (CCC) are calculated, and both the time-course change and the comparison among the 3 groups are tested.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Prospective Study to Examine the Efficacy of a Capsular Tension Ring (CTR) in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome (XFS) With no Zonular Weakness
    Study Start Date :
    Sep 1, 2004
    Actual Primary Completion Date :
    May 1, 2006
    Anticipated Study Completion Date :
    Oct 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    No treatment

    Capsular tension ring is not used in the group.

    CTR simply implanted

    Capsular tension ring is simply implanted in the group.

    CTR with the eyelets closed

    Capsular tension ring is implanted and closed by tying both eyelets in the group.

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome [3 years]

      The vertical diameters (A mm) and horizontal diameters (B mm) of the postoperative capsulorhexis opening were measured using the scale of a Haag-Strait slit lamp. The area of the rhexis is equal to πAB/4 mm2. The measurements are taken on day one (baseline), and thereafter at each weeks postoperatively. The statistical analyses are used for time-course changes in each group, and for the area among the three groups on the same postoperative period. For this study, the percent change is calculated based on the ratio of the area at each measurement in comparison to the initial value.

    2. Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome [3 years]

      The vertical diameters (A mm) and horizontal diameters (B mm) of the postoperative capsulorhexis opening are measured using the scale of a Haag-Strait slit lamp. The area of the rhexis is equal to πAB/4 mm2. The measurements are taken on day one (baseline), and thereafter at each weeks postoperatively. The statistical analyses are used for time-course changes in each group, and for the area among the three groups on the same postoperative period. For this study, the percent change is calculated based on the ratio of the area at each measurement in comparison to the initial value.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eyes with exfoliation syndrome are included.
    Exclusion Criteria:
    • Eyes with either ectopia lentis or phacodonesis are excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Occupational and Environmental Health Kitakyushu Fukuoka Japan 807-8555

    Sponsors and Collaborators

    • University of Occupational and Environmental Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yukinori Harada, Assistant Professor, University of Occupational and Environmental Health
    ClinicalTrials.gov Identifier:
    NCT01455168
    Other Study ID Numbers:
    • H23-75
    • H23-75
    First Posted:
    Oct 19, 2011
    Last Update Posted:
    Oct 20, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Yukinori Harada, Assistant Professor, University of Occupational and Environmental Health
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 20, 2011