NCT01598428

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

May 8, 2012

Results QC Date

June 17, 2014

Last Update Submit

January 14, 2015

Conditions

Cataract

Keywords

age related cataractphacoemulsificationanterior capsule polishingoptical coherence tomographyanterior chamber depth

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Uncorrected Visual Acuity(UCVA)

    1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

  • Refractive Error

    1 day，1 week, 1 month as well as 3 months and 6 months postoperatively

Study Arms (1)

cataract

OTHER
Procedure: anterior capsule polishing

Interventions

anterior capsule polishingPROCEDURE

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

cataract

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophtalmology,Qianfoshan Hospital,Shandong University

Jinan, Shandong, 250013, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Dr.Yang Gao
Organization
Shandong University
pinkapples@126.com
0086-543-89268587

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 15, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 26, 2015

Results First Posted

January 26, 2015

Record last verified: 2015-01

Locations

CN(1)