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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00762606
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
21
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Phacoemulsification cataract extraction surgery
  • Procedure: Small incision cataract surgery
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Phaco

Cataract extraction surgery utilizing Phacoemulsification

Procedure: Phacoemulsification cataract extraction surgery
Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)

Active Comparator: SICS

Small incision cataract surgery (SICS)

Procedure: Small incision cataract surgery
Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).

Outcome Measures

Primary Outcome Measures

  1. Posterior Capsule Opacification Evaluation [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.

Secondary Outcome Measures

  1. Corneal Astigmatism [3 months after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL);

  • Pupil dilation ≧7 mm after mydrisis;

  • Patient undergoing cataract surgery for the first eye;

  • VA prognosis ≧6/12

Exclusion Criteria:
  • Patients with history of ocular pathology or diabetic retinopathy;

  • Patients with traumatic, subluxated and posterior polar cataract;

  • Patients had ocular surgery in the past 6 months;

  • Patients with significant intra-operative complications

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon Call CenterFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00762606
Other Study ID Numbers:
  • RM-08-002
First Posted:
Sep 30, 2008
Last Update Posted:
Oct 31, 2012
Last Verified:
Aug 1, 2011
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePhacoSICS
Arm/Group Descriptioncataract extraction surgery utilizing PhacoemulsificationSmall incision cataract surgery (SICS)
Period Title: Overall Study
STARTED5551
COMPLETED3738
NOT COMPLETED1813

Baseline Characteristics

Arm/Group TitlePhacoSICSTotal
Arm/Group Descriptioncataract extraction surgery utilizing PhacoemulsificationSmall incision cataract surgery (SICS)Total of all reporting groups
Overall Participants5551106
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
8
14.5%
11
21.6%
19
17.9%
>=65 years
47
85.5%
40
78.4%
87
82.1%
Sex: Female, Male (Count of Participants)
Female
33
60%
31
60.8%
64
60.4%
Male
22
40%
20
39.2%
42
39.6%

Outcome Measures

1. Primary Outcome
TitlePosterior Capsule Opacification Evaluation
DescriptionThe 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.
Time Frame12 months after surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePhacoSICS
Arm/Group Descriptioncataract extraction surgery utilizing PhacoemulsificationSmall incision cataract surgery (SICS)
Measure Participants3638
Number [participants]
3
5.5%
28
54.9%
2. Secondary Outcome
TitleCorneal Astigmatism
DescriptionAnalysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
Time Frame3 months after surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePhacoSICS
Arm/Group Descriptioncataract extraction surgery utilizing PhacoemulsificationSmall incision cataract surgery (SICS)
Measure Participants5551
Mean (Standard Deviation) [Diopters]
1.05
(0.80)
1.95
(1.15)

Adverse Events

Time FrameDuring surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
Adverse Event Reporting Description
Arm/Group TitlePhacoSICS
Arm/Group Descriptioncataract extraction surgery utilizing PhacoemulsificationSmall incision cataract surgery (SICS)
All Cause Mortality
PhacoSICS
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
PhacoSICS
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/55 (0%) 0/51 (0%)
Other (Not Including Serious) Adverse Events
PhacoSICS
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/55 (3.6%) 6/51 (11.8%)
Eye disorders
Posterior Capsular Rupture2/55 (3.6%) 23/51 (5.9%) 3
Conjunctival Congestion0/55 (0%) 01/51 (2%) 1
Zonular Rupture0/55 (0%) 01/51 (2%) 1
Musculoskeletal and connective tissue disorders
Femoral Fracture0/55 (0%) 01/51 (2%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleDirector of Alcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00762606
Other Study ID Numbers:
  • RM-08-002
First Posted:
Sep 30, 2008
Last Update Posted:
Oct 31, 2012
Last Verified:
Aug 1, 2011