Overview

This trial is active, not recruiting.

Condition cataract with exfoliation syndrome
Phase phase 3
Sponsor University of Occupational and Environmental Health
Start date September 2004
End date May 2006
Trial size 30 participants
Trial identifier NCT01455168, H23-75

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Capsular tension ring is not used in the group.
Capsular tension ring is simply implanted in the group.
Capsular tension ring is implanted and closed by tying both eyelets in the group.

Primary Outcomes

Measure
Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome
time frame: 3 years
Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome
time frame: 3 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Eyes with exfoliation syndrome are included. Exclusion Criteria: - Eyes with either ectopia lentis or phacodonesis are excluded.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by University of Occupational and Environmental Health.