Anterior Capsule Polishing Effect on Effective Lens Position

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598428
• Other study ID #: YGao
• Status: Completed
• Phase: N/A
• First received: May 8, 2012
• Last updated: January 14, 2015
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
China	Department of Ophtalmology,Qianfoshan Hospital,Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective Lens Position	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	Yes
Secondary	Uncorrected Visual Acuity(UCVA)	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	Yes
Secondary	Refractive Error	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	Yes