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Trial Outcomes & Findings for Outcomes of 3 Incision-size-dependent Phacoemulsification Systems (NCT NCT01429532)

NCT ID: NCT01429532

Last Updated: 2014-07-11

Results Overview

Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.

Recruitment status

COMPLETED

Target enrollment

120 participants

Primary outcome timeframe

post-operative week 1, post-operative month 1, and post-operative month 3

Results posted on

2014-07-11

Participant Flow

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.

Potential subjects with previous intraocular surgery, glaucoma, pseudoexfoliation, uveitis, high myopia and diabetes mellitus were excluded from participation in the study.

Participant milestones

Participant milestones
Measure
Group I
1.8-mm-incision-size phacoemulsification system
Group II
2.2-mm-incision-size phacoemulsification system
Group III
3.0-mm-incision-size phacoemulsification system
Overall Study
STARTED
40
40
40
Overall Study
COMPLETED
40
40
40
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes of 3 Incision-size-dependent Phacoemulsification Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group I
n=40 Participants
1.8-mm-incision-size phacoemulsification system
Group II
n=40 Participants
2.2-mm-incision-size phacoemulsification system
Group III
n=40 Participants
3.0-mm-incision-size phacoemulsification system
Total
n=120 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
12 Participants
n=7 Participants
12 Participants
n=5 Participants
36 Participants
n=4 Participants
Age, Categorical
>=65 years
28 Participants
n=5 Participants
28 Participants
n=7 Participants
28 Participants
n=5 Participants
84 Participants
n=4 Participants
Age, Continuous
73.95 years
STANDARD_DEVIATION 6.05 • n=5 Participants
71.37 years
STANDARD_DEVIATION 7.19 • n=7 Participants
72.48 years
STANDARD_DEVIATION 6.15 • n=5 Participants
72.59 years
STANDARD_DEVIATION 6.32 • n=4 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
22 Participants
n=7 Participants
21 Participants
n=5 Participants
62 Participants
n=4 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
18 Participants
n=7 Participants
19 Participants
n=5 Participants
58 Participants
n=4 Participants
Region of Enrollment
China
40 participants
n=5 Participants
40 participants
n=7 Participants
40 participants
n=5 Participants
120 participants
n=4 Participants

PRIMARY outcome

Timeframe: post-operative week 1, post-operative month 1, and post-operative month 3

Population: 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.

Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.

Outcome measures

Outcome measures
Measure
Group I
n=40 Participants
1.8-mm-incision-size phacoemulsification system
Group II
n=40 Participants
2.2-mm-incision-size phacoemulsification system
Group III
n=40 Participants
3.0-mm-incision-size phacoemulsification system
Central Cornea Endothelial Cell Loss
Post-op 1m
11.78 % of endothelial cell loss
Standard Deviation 7.27
13.03 % of endothelial cell loss
Standard Deviation 8.33
12.05 % of endothelial cell loss
Standard Deviation 9.31
Central Cornea Endothelial Cell Loss
Post-op 1 w
7.77 % of endothelial cell loss
Standard Deviation 3.76
9.35 % of endothelial cell loss
Standard Deviation 4.69
7.93 % of endothelial cell loss
Standard Deviation 3.67
Central Cornea Endothelial Cell Loss
Post-op 3 month
17.83 % of endothelial cell loss
Standard Deviation 5.65
18.08 % of endothelial cell loss
Standard Deviation 7.93
17.66 % of endothelial cell loss
Standard Deviation 5.26

PRIMARY outcome

Timeframe: post-operative week 1, post-operative month 1, and post-operative month 3

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.

Outcome measures

Outcome measures
Measure
Group I
n=40 Participants
1.8-mm-incision-size phacoemulsification system
Group II
n=40 Participants
2.2-mm-incision-size phacoemulsification system
Group III
n=40 Participants
3.0-mm-incision-size phacoemulsification system
Surgically Induced Astigmatism
Post-op 1 day
1.2 Diopters
Standard Deviation 0.32
0.91 Diopters
Standard Deviation 0.34
0.951 Diopters
Standard Deviation 0.28
Surgically Induced Astigmatism
Post-op 1 week
0.61 Diopters
Standard Deviation 0.24
0.74 Diopters
Standard Deviation 0.25
0.79 Diopters
Standard Deviation 0.23
Surgically Induced Astigmatism
Post-op 1 month
0.4 Diopters
Standard Deviation 0.21
0.46 Diopters
Standard Deviation 0.24
0.75 Diopters
Standard Deviation 0.31
Surgically Induced Astigmatism
Post-op 3 months
0.26 Diopters
Standard Deviation 0.18
0.31 Diopters
Standard Deviation 0.19
0.66 Diopters
Standard Deviation 0.21

SECONDARY outcome

Timeframe: post-operative week 1, post-operative month 1, and post-operative month 3

Population: The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.

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.

Outcome measures

Outcome measures
Measure
Group I
n=40 Participants
1.8-mm-incision-size phacoemulsification system
Group II
n=40 Participants
2.2-mm-incision-size phacoemulsification system
Group III
n=40 Participants
3.0-mm-incision-size phacoemulsification system
Best-corrected Visual Acuity
Pre-op 1 day
0.16 logMAR
Standard Deviation 0.10
0.13 logMAR
Standard Deviation 0.11
0.15 logMAR
Standard Deviation 0.11
Best-corrected Visual Acuity
Post-op 1 day
0.66 logMAR
Standard Deviation 0.27
0.71 logMAR
Standard Deviation 0.20
0.73 logMAR
Standard Deviation 0.23
Best-corrected Visual Acuity
Post-op 1 month
0.89 logMAR
Standard Deviation 0.20
0.91 logMAR
Standard Deviation 0.13
0.88 logMAR
Standard Deviation 0.14
Best-corrected Visual Acuity
Post-op 3 months
0.98 logMAR
Standard Deviation 0.11
1.01 logMAR
Standard Deviation 0.09
0.98 logMAR
Standard Deviation 0.10

Adverse Events

Group I

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group II

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group III

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Yizhi Liu

SunYat-senU

Phone: +86-20-87330341

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60