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Anterior Capsule Polishing Effect on Effective Lens Position

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ClinicalTrials.gov Identifier: NCT01598428
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Yang Gao, Shandong University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Cataract
Intervention Procedure: anterior capsule polishing
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cataract
Hide Arm/Group Description During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Cataract
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
70.5  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 20 participants
20
1.Primary Outcome
Title Effective Lens Position
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Anterior Capsule Polishing
Hide Arm/Group Description:
During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Overall Number of Participants Analyzed 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
20 20
Mean (Standard Deviation)
Unit of Measure: mm
ELP 1 day postoperative 3.97  (0.27) 4.02  (0.32)
ELP 1 week postoperative 3.93  (0.25) 3.99  (0.29)
ELP 1 month postoperative 3.97  (0.23) 3.99  (0.26)
ELP 3 months postoperative 3.98  (0.24) 3.97  (0.27)
ELP 6 months postoperative 3.92  (0.25) 3.97  (0.28)
the root mean square of changes in the ELP(ELPrms) 0.06  (0.02) 0.05  (0.02)
2.Secondary Outcome
Title Uncorrected Visual Acuity(UCVA)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Anterior Capsule Polishing
Hide Arm/Group Description:
During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Overall Number of Participants Analyzed 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
20 20
Mean (Standard Deviation)
Unit of Measure: logMAR
UCVA 1 day postoperative 0.07  (0.10) 0.07  (0.09)
UCVA 1 week postoperative 0.08  (0.09) 0.08  (0.09)
UCVA 1 month postoperative 0.09  (0.10) 0.08  (0.09)
UCVA 3 months postoperative 0.10  (0.12) 0.10  (0.08)
UCVA 6 months postoperative 0.10  (0.11) 0.10  (0.08)
3.Secondary Outcome
Title Refractive Error
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Anterior Capsule Polishing
Hide Arm/Group Description:
During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Overall Number of Participants Analyzed 20 20
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
20 20
Mean (Standard Deviation)
Unit of Measure: diopter(D)
the refractive error 1 day postoperative -0.33  (0.18) -0.45  (0.18)
the refractive error 1 week postoperative -0.42  (0.26) -0.53  (0.44)
the refractive error 1 month postoperative -0.37  (0.24) -0.46  (0.47)
the refractive error 3 month postoperative -0.36  (0.23) -0.48  (0.22)
the refractive error 6 months postoperative -0.41  (0.22) -0.48  (0.21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cataract
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Cataract
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cataract
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cataract
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Yang Gao
Organization: Shandong University
Phone: 0086-543-89268587
EMail: pinkapples@126.com
Layout table for additonal information
Responsible Party: Yang Gao, Shandong University
ClinicalTrials.gov Identifier: NCT01598428    
Other Study ID Numbers: YGao
First Submitted: May 8, 2012
First Posted: May 15, 2012
Results First Submitted: June 17, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015