Anterior Capsule Polishing Effect on Intraocular Lens (IOL) Position

This study is not yet open for participant recruitment.

Verified May 2012 by Shandong University

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

History of Changes

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:

MedlinePlus related topics: Cataract

U.S. FDA Resources

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

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 May 21, 2013

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