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

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

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 Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Alcon Call Center	Fort Worth	Texas	United States	76134

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: Cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Phaco	SICS
Arm/Group Description	cataract extraction surgery utilizing Phacoemulsification	Small incision cataract surgery (SICS)
Period Title: Overall Study
STARTED	55	51
COMPLETED	37	38
NOT COMPLETED	18	13

Baseline Characteristics

Arm/Group Title	Phaco	SICS	Total
Arm/Group Description	cataract extraction surgery utilizing Phacoemulsification	Small incision cataract surgery (SICS)	Total of all reporting groups
Overall Participants	55	51	106
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

Title	Posterior Capsule Opacification Evaluation
Description	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.
Time Frame	12 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phaco	SICS
Arm/Group Description	cataract extraction surgery utilizing Phacoemulsification	Small incision cataract surgery (SICS)
Measure Participants	36	38
Number [participants]	3 5.5%	28 54.9%

2. Secondary Outcome

Title	Corneal Astigmatism
Description	Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.
Time Frame	3 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phaco	SICS
Arm/Group Description	cataract extraction surgery utilizing Phacoemulsification	Small incision cataract surgery (SICS)
Measure Participants	55	51
Mean (Standard Deviation) [Diopters]	1.05 (0.80)	1.95 (1.15)

Adverse Events

Time Frame	During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.
Arm/Group Title	Phaco		SICS
Arm/Group Description	cataract extraction surgery utilizing Phacoemulsification		Small incision cataract surgery (SICS)
All Cause Mortality
	Phaco		SICS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Phaco		SICS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Phaco		SICS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/55 (3.6%)		6/51 (11.8%)
Eye disorders
Posterior Capsular Rupture	2/55 (3.6%)	2	3/51 (5.9%)	3
Conjunctival Congestion	0/55 (0%)	0	1/51 (2%)	1
Zonular Rupture	0/55 (0%)	0	1/51 (2%)	1
Musculoskeletal and connective tissue disorders
Femoral Fracture	0/55 (0%)	0	1/51 (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.