Back to resultsAnterior Capsule Polishing Effect on Effective Lens Position
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anterior capsule polishing
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract focused on measuring age related cataract, phacoemulsification, anterior capsule polishing, optical coherence tomography, anterior chamber depth
Eligibility 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
Sites / Locations
- Department of Ophtalmology,Qianfoshan Hospital,Shandong University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cataract
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Uncorrected Visual Acuity(UCVA)
The UCVA was recorded in logMAR units at each vist
Refractive Error
auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598428
Brief Title
Anterior Capsule Polishing Effect on Effective Lens Position
Official Title
Effect of Anterior Capsule Polishing on Effective Lens Position After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
age related cataract, phacoemulsification, anterior capsule polishing, optical coherence tomography, anterior chamber depth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cataract
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
anterior capsule polishing
Intervention Description
polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Primary Outcome Measure Information:
Title
Effective Lens Position
Description
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.
Time Frame
1 day，1 week, 1 month，3 months and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Uncorrected Visual Acuity(UCVA)
Description
The UCVA was recorded in logMAR units at each vist
Time Frame
1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
Title
Refractive Error
Description
auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.
Time Frame
1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Ophtalmology,Qianfoshan Hospital,Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
12. IPD Sharing Statement
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Anterior Capsule Polishing Effect on Effective Lens Position
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