Cataract With Exfoliation Syndrome Clinical Trial
— Effect of CTROfficial 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
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.
| Status | Active, not recruiting |
| Enrollment | 30 |
| Est. completion date | October 2013 |
| Est. primary completion date | May 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Eyes with exfoliation syndrome are included. Exclusion Criteria: - Eyes with either ectopia lentis or phacodonesis are excluded. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | University of Occupational and Environmental Health | Kitakyushu | Fukuoka |
| Lead Sponsor | Collaborator |
|---|---|
| University of Occupational and Environmental Health |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 pAB/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 | Yes |
| Primary | 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 pAB/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 | Yes |