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Completed

NCT Number: NCT01598428

Anterior Capsule Polishing Effect on Effective Lens Position

* 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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophtalmology,Qianfoshan Hospital,Shandong University

Jinan, Shandong, 250013, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior capsule polishing

Procedure

polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2012
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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