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

NCT01455168 | Unknown

• 1 other identifier: H23-75
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract With Exfoliation Syndrome

Keywords

anterior capsule shrinkage; capsular tension ring; exfoliation syndrome; phacoemulsification and aspiration

Outcome Measures

Primary Outcomes (2)

• Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome

  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.

  3 years

• Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage after Cataract Surgery in Exfoliation Syndrome

  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.

  3 years

Study Arms (3)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with cataract and exfoliation syndrome

You may qualify if:

• Eyes with exfoliation syndrome are included.

You may not qualify if:

• Eyes with either ectopia lentis or phacodonesis are excluded.

Sponsors & Collaborators

• University of Occupational and Environmental Health: lead

Study Sites (1)

University of Occupational and Environmental Health

Kitakyushu, Fukuoka, 807-8555, Japan

Location

MeSH Terms

Conditions

Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2011
• First Posted: October 19, 2011
• Study Start: September 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: October 1, 2013
• Last Updated: October 20, 2011

Record last verified: 2011-10

Locations

JP (1)