Anterior Capsule Polishing Effect on Intraocular Lens (IOL) Position

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Shandong University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Yang Gao, Shandong University
ClinicalTrials.gov Identifier:
NCT01598428
First received: May 8, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to examine effects of anterior capsule polishing on the position of the intraocular lens (IOL), posterior capsule opacification (PCO), anterior capsule opacification (ACO) as well as the area of the capsulorhexis opening size. The patients with bilateral age-related cataract undergo phacoemulsification and aspiration (PEA) with an intraocular lens (IOL) implantation. Patients were randomly assigned to have extensive anterior capsule polishing with the aspiration curette or no treatment in the first eye; the second eye received the opposite treatment. All operations are performed by a single surgeon. The central anterior chamber depth (ACD) was measured by AS-OCT (Visante), the area of the anterior capsule opening and the Digital slitlamp photographs of the ACO and PCO taken with a standardized technique was measured 1 day and 1, 3, 6 months postoperatively.


Condition Intervention
Cataract
Procedure: polish the anterior capsule of len extensively

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Anterior Capsule Polishing on the Anteroposterior Position of the Intraocular Lens

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Effect of Anterior Capsule Polishing on the anteroposterior Position of the Intraocular Lens [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The central anterior chamber depth (ACD) was measured by AS-OCT (Visante), the area of the anterior capsule opening and the Digital slitlamp photographs of the anterior capsule opacification (ACO) and posterior capsule opacification (PCO), as well as the area of the capsulorhexis opening sizePCO taken with a standardized technique was measured 1 day and 1, 3, 6 months postoperatively.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No treatment
the anterior capsule was not polished in the group
Active Comparator: anterior capsule polished
the anterior capsule was extensively polished in the group
Procedure: polish the anterior capsule of len extensively
polish the anterior capsule of len extensively

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with bilateral age-related cataract

Exclusion Criteria:

  • history of ocular disease or intraocular surgery,
  • laser treatment,
  • diabetes requiring medications,
  • glaucoma, and
  • severe retinal pathology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Yang Gao, Principal Investigator, Shandong University
ClinicalTrials.gov Identifier: NCT01598428     History of Changes
Other Study ID Numbers: YGao
Study First Received: May 8, 2012
Last Updated: May 14, 2012
Health Authority: China: Ethics Committee

Keywords provided by Shandong University:
phacoemulsification and aspiration
Capsule Opacifications
Optical Coherence Tomography

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 18, 2014