Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome (Effect of CTR)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Occupational and Environmental Health
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
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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.
| 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 |
|---|
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No treatment
Capsular tension ring is not used in the group.
|
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CTR simply implanted
Capsular tension ring is simply implanted in the group.
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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 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 Lens Diseases |
Eye Diseases Iris Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013