Anterior Capsule Polishing Effect on Effective Lens Position

January 14, 2015 updated by: Yang Gao, Shandong University

Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery

  • The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)
  • patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250013
        • Department of Ophtalmology,Qianfoshan Hospital,Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilateral age-related cataract
  • good overall physical constitution
  • uneventful surgeries of both eyes with in-the-bag IOL implantation

Exclusion Criteria:

  • history of intraocular surgery or laser therapy
  • history of ocular trauma or ocular disease
  • high myopia
  • diabetes
  • severe retinal pathology
  • patients who could not return on time

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: cataract
Procedure: anterior capsule polishing
polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Lens Position
Time Frame: 1 day，1 week, 1 month，3 months and 6 months postoperatively
Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.
1 day，1 week, 1 month，3 months and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Visual Acuity(UCVA)
Time Frame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
The UCVA was recorded in logMAR units at each vist
1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
Refractive Error
Time Frame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.
1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (ESTIMATE)

May 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YGao

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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