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

September 24, 2011
October 19, 2011
September 2004
May 2006   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01455168 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of a Capsular Tension Ring in Preventing Anterior Capsule Shrinkage After Cataract Surgery in Exfoliation Syndrome
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Outpatients with cataract and exfoliation syndrome

Cataract With Exfoliation Syndrome
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2013
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eyes with exfoliation syndrome are included.

Exclusion Criteria:

  • Eyes with either ectopia lentis or phacodonesis are excluded.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01455168
H23-75, H23-75
No
Yukinori Harada, University of Occupational and Environmental Health
University of Occupational and Environmental Health
Not Provided
Not Provided
University of Occupational and Environmental Health
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP