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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Occupational and Environmental Health.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yukinori Harada, University of Occupational and Environmental Health
ClinicalTrials.gov Identifier:
NCT01455168
First received: September 24, 2011
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

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 Phase
Cataract With Exfoliation Syndrome
Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Occupational and Environmental Health:

Primary Outcome Measures:
  • Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.

  • Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: September 2004
Estimated Study Completion Date: October 2013
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients with cataract and exfoliation syndrome

Criteria

Inclusion Criteria:

  • Eyes with exfoliation syndrome are included.

Exclusion Criteria:

  • Eyes with either ectopia lentis or phacodonesis are excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455168

Locations
Japan
University of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan, 807-8555
Sponsors and Collaborators
University of Occupational and Environmental Health
  More Information

No publications provided

Responsible Party: Yukinori Harada, Assistant Professor, University of Occupational and Environmental Health
ClinicalTrials.gov Identifier: NCT01455168     History of Changes
Other Study ID Numbers: H23-75, H23-75
Study First Received: September 24, 2011
Last Updated: October 19, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by University of Occupational and Environmental Health:
anterior capsule shrinkage
capsular tension ring
exfoliation syndrome
phacoemulsification and aspiration

Additional relevant MeSH terms:
Cataract
Exfoliation Syndrome
Capsule Opacification
Lens Diseases
Eye Diseases
Iris Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on August 26, 2014