Anterior Capsule Polishing Effect on Effective Lens Position

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yang Gao, Shandong University
ClinicalTrials.gov Identifier:
NCT01598428
First received: May 8, 2012
Last updated: January 14, 2015
Last verified: January 2015
  Purpose
  • 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.

Condition Intervention
Cataract
Procedure: anterior capsule polishing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • Effective Lens Position [ Time Frame: 1 day,1 week, 1 month,3 months and 6 months postoperatively ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Uncorrected Visual Acuity(UCVA) [ Time Frame: 1 day,1 week, 1 month as well as 3 months and 6 months postoperatively ] [ Designated as safety issue: Yes ]
    The UCVA was recorded in logMAR units at each vist

  • Refractive Error [ Time Frame: 1 day,1 week, 1 month as well as 3 months and 6 months postoperatively ] [ Designated as safety issue: Yes ]
    auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.


Enrollment: 20
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
cataract Procedure: anterior capsule polishing
polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598428

Locations
China, Shandong
Department of Ophtalmology,Qianfoshan Hospital,Shandong University
Jinan, Shandong, China, 250013
Sponsors and Collaborators
Shandong University
  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
Results First Received: June 17, 2014
Last Updated: January 14, 2015
Health Authority: China: Ethics Committee

Keywords provided by Shandong University:
age related cataract
phacoemulsification
anterior capsule polishing
optical coherence tomography
anterior chamber depth

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 21, 2015