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Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

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ClinicalTrials.gov Identifier: NCT01429532
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Collaborators:
Ministry of Health, China
National Natural Science Foundation of China
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Cataract
Intervention Procedure: phacoemulsification
Enrollment 120
Recruitment Details This prospective randomized study included 120 patients (120 eyes) with age-related cataract enrolled between July 2010 and January 2011 at the Zhong-shan Ophthalmic Center, Guangzhou, China.
Pre-assignment Details Potential subjects with previous intraocular surgery, glaucoma, pseudoexfoliation, uveitis, high myopia and diabetes mellitus were excluded from participation in the study.
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description 1.8-mm-incision-size phacoemulsification system 2.2-mm-incision-size phacoemulsification system 3.0-mm-incision-size phacoemulsification system
Period Title: Overall Study
Started 40 40 40
Completed 40 40 40
Not Completed 0 0 0
Arm/Group Title Group I Group II Group III Total
Hide Arm/Group Description 1.8-mm-incision-size phacoemulsification system 2.2-mm-incision-size phacoemulsification system 3.0-mm-incision-size phacoemulsification system Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  30.0%
12
  30.0%
12
  30.0%
36
  30.0%
>=65 years
28
  70.0%
28
  70.0%
28
  70.0%
84
  70.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 120 participants
73.95  (6.05) 71.37  (7.19) 72.48  (6.15) 72.59  (6.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 120 participants
Female
19
  47.5%
22
  55.0%
21
  52.5%
62
  51.7%
Male
21
  52.5%
18
  45.0%
19
  47.5%
58
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 40 participants 40 participants 40 participants 120 participants
40 40 40 120
1.Primary Outcome
Title Central Cornea Endothelial Cell Loss
Hide Description Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.
Time Frame post-operative week 1, post-operative month 1, and post-operative month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis and sample size calculation. Mean ultrasound time (UST), surgical time, cumulative dissipated energy (CDE), total BSS volume, and SIA were compared using multifactor analysis of variance.
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description:
1.8-mm-incision-size phacoemulsification system
2.2-mm-incision-size phacoemulsification system
3.0-mm-incision-size phacoemulsification system
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: % of endothelial cell loss
Post-op 1m 11.78  (7.27) 13.03  (8.33) 12.05  (9.31)
Post-op 1 w 7.77  (3.76) 9.35  (4.69) 7.93  (3.67)
Post-op 3 month 17.83  (5.65) 18.08  (7.93) 17.66  (5.26)
2.Primary Outcome
Title Surgically Induced Astigmatism
Hide Description Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.
Time Frame post-operative week 1, post-operative month 1, and post-operative month 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description:
1.8-mm-incision-size phacoemulsification system
2.2-mm-incision-size phacoemulsification system
3.0-mm-incision-size phacoemulsification system
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: Diopters
Post-op 1 day 1.2  (0.32) 0.91  (0.34) 0.951  (0.28)
Post-op 1 week 0.61  (0.24) 0.74  (0.25) 0.79  (0.23)
Post-op 1 month 0.4  (0.21) 0.46  (0.24) 0.75  (0.31)
Post-op 3 months 0.26  (0.18) 0.31  (0.19) 0.66  (0.21)
3.Secondary Outcome
Title Best-corrected Visual Acuity
Hide Description The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months.
Time Frame post-operative week 1, post-operative month 1, and post-operative month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description:
1.8-mm-incision-size phacoemulsification system
2.2-mm-incision-size phacoemulsification system
3.0-mm-incision-size phacoemulsification system
Overall Number of Participants Analyzed 40 40 40
Mean (Standard Deviation)
Unit of Measure: logMAR
Pre-op 1 day 0.16  (0.10) 0.13  (0.11) 0.15  (0.11)
Post-op 1 day 0.66  (0.27) 0.71  (0.20) 0.73  (0.23)
Post-op 1 month 0.89  (0.20) 0.91  (0.13) 0.88  (0.14)
Post-op 3 months 0.98  (0.11) 1.01  (0.09) 0.98  (0.10)
Time Frame [Not Specified]
Adverse Event Reporting Description Total Number of Participants at Risk for this Observational Study (e.g., serious and/or other [non-serious] adverse events were not collected/assessed).
 
Arm/Group Title Group I Group II Group III
Hide Arm/Group Description 1.8-mm-incision-size phacoemulsification system 2.2-mm-incision-size phacoemulsification system 3.0-mm-incision-size phacoemulsification system
All-Cause Mortality
Group I Group II Group III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group I Group II Group III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group I Group II Group III
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof. Yizhi Liu
Organization: SunYat-senU
Phone: +86-20-87330341
Responsible Party: Haotian Lin, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01429532     History of Changes
Other Study ID Numbers: CCPMOH2010-China2
First Submitted: September 4, 2011
First Posted: September 7, 2011
Results First Submitted: December 25, 2012
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014