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Trial Outcomes & Findings for Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study (NCT NCT00762606)

NCT ID: NCT00762606

Last Updated: 2012-10-31

Results Overview

The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

12 months after surgery

Results posted on

2012-10-31

Participant Flow

Participant milestones

Participant milestones
Measure
Phaco
cataract extraction surgery utilizing Phacoemulsification
SICS
Small incision cataract surgery (SICS)
Overall Study
STARTED
55
51
Overall Study
COMPLETED
37
38
Overall Study
NOT COMPLETED
18
13

Reasons for withdrawal

Reasons for withdrawal
Measure
Phaco
cataract extraction surgery utilizing Phacoemulsification
SICS
Small incision cataract surgery (SICS)
Overall Study
Lost to Follow-up
18
13

Baseline Characteristics

Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phaco
n=55 Participants
cataract extraction surgery utilizing Phacoemulsification
SICS
n=51 Participants
Small incision cataract surgery (SICS)
Total
n=106 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
Age, Categorical
Between 18 and 65 years
8 Participants
n=5 Participants
11 Participants
n=7 Participants
19 Participants
n=5 Participants
Age, Categorical
>=65 years
47 Participants
n=5 Participants
40 Participants
n=7 Participants
87 Participants
n=5 Participants
Sex: Female, Male
Female
33 Participants
n=5 Participants
31 Participants
n=7 Participants
64 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
20 Participants
n=7 Participants
42 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 12 months after surgery

The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.

Outcome measures

Outcome measures
Measure
Phaco
n=36 Participants
cataract extraction surgery utilizing Phacoemulsification
SICS
n=38 Participants
Small incision cataract surgery (SICS)
Posterior Capsule Opacification Evaluation
3 participants
28 participants

SECONDARY outcome

Timeframe: 3 months after surgery

Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.

Outcome measures

Outcome measures
Measure
Phaco
n=55 Participants
cataract extraction surgery utilizing Phacoemulsification
SICS
n=51 Participants
Small incision cataract surgery (SICS)
Corneal Astigmatism
1.05 Diopters
Standard Deviation 0.80
1.95 Diopters
Standard Deviation 1.15

Adverse Events

Phaco

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

SICS

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Phaco
n=55 participants at risk
cataract extraction surgery utilizing Phacoemulsification
SICS
n=51 participants at risk
Small incision cataract surgery (SICS)
Eye disorders
Posterior Capsular Rupture
3.6%
2/55 • Number of events 2 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
5.9%
3/51 • Number of events 3 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
Eye disorders
Conjunctival Congestion
0.00%
0/55 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
2.0%
1/51 • Number of events 1 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
Musculoskeletal and connective tissue disorders
Femoral Fracture
0.00%
0/55 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
2.0%
1/51 • Number of events 1 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
Eye disorders
Zonular Rupture
0.00%
0/55 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
2.0%
1/51 • Number of events 1 • During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Results disclosure agreements

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