Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762021
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: SN60AT; Device: SN60WF	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SN60AT Implantation with the AcrySof Intraocular Lens Model SN60AT	Device: SN60AT; Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal.
Active Comparator: SN60WF Implantation with the AcrySof Intraocular Lens Model SN60WF	Device: SN60WF; Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal.

Outcome Measures

Primary Outcome Measures

1. Posterior Capsule Opacification (PCO) [2 years after surgery]

   Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.

2. 100% LogMAR Best Corrected Visual Acuity (BCVA) [24 months after surgery]

   Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

3. 9% LogMAR Best Corrected Visual Acuity (BCVA) [24 months after surgery]

   Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with bilateral senile cataracts

• Age > 50 years

• Fit for hospital follow ups

• Pupils dilating > 6mm preoperatively

• Eyes expected to see 6/12 or better postoperatively

Exclusion Criteria:

• Diabetes

• On treatment for glaucoma

• Other ocular pathology

• Previous ocular surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	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.

• ClinicalTrials.gov Identifier: NCT00762021
• Other Study ID Numbers: P-06-26
• First Posted: Sep 30, 2008
• Last Update Posted: Dec 22, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Uncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye
Pre-assignment Detail	During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.

Arm/Group Title	SN60AT	SN60WF
Arm/Group Description	Implantation with the AcrySof Intraocular Lens Model SN60AT	Implantation with the AcrySof Intraocular Lens Model SN60WF
Period Title: Overall Study
STARTED	52	52
COMPLETED	44	44
NOT COMPLETED	8	8

Baseline Characteristics

Arm/Group Title	SN60AT	SN60WF	Total
Arm/Group Description	Implantation with the AcrySof Intraocular Lens Model SN60AT	Implantation with the AcrySof Intraocular Lens Model SN60WF	Total of all reporting groups
Overall Participants	52	52	104
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 23.1%	12 23.1%	24 23.1%
>=65 years	40 76.9%	40 76.9%	80 76.9%
Sex: Female, Male (Count of Participants)
Female	29 55.8%	29 55.8%	58 55.8%
Male	23 44.2%	23 44.2%	46 44.2%

Outcome Measures

1. Primary Outcome

Title	Posterior Capsule Opacification (PCO)
Description	Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.
Time Frame	2 years after surgery

Outcome Measure Data

Analysis Population Description

Data for all patients completing the 24 month visit were analyzed.

Arm/Group Title	SN60AT	SN60WF
Arm/Group Description	Implantation with the AcrySof Intraocular Lens Model SN60AT	Implantation with the AcrySof Intraocular Lens Model SN60WF
Measure Participants	40	40
Mean (Standard Deviation) [Percentage of PCO]	11.58 (20.18)	14.04 (22.15)

2. Primary Outcome

Title	100% LogMAR Best Corrected Visual Acuity (BCVA)
Description	Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame	24 months after surgery

Outcome Measure Data

Analysis Population Description

Data for all patients completing the 24 month visit were analyzed.

Arm/Group Title	SN60AT	SN60WF
Arm/Group Description	Implantation with the AcrySof Intraocular Lens Model SN60AT	Implantation with the AcrySof Intraocular Lens Model SN60WF
Measure Participants	40	40
Mean (Standard Deviation) [LogMAR]	0.04 (0.1)	0.07 (0.2)

3. Primary Outcome

Title	9% LogMAR Best Corrected Visual Acuity (BCVA)
Description	Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame	24 months after surgery

Outcome Measure Data

Analysis Population Description

Data for all patients completing the 24 month visit were analyzed.

Arm/Group Title	SN60AT	SN60WF
Arm/Group Description	Implantation with the AcrySof Intraocular Lens Model SN60AT	Implantation with the AcrySof Intraocular Lens Model SN60WF
Measure Participants	40	40
Mean (Standard Deviation) [LogMAR]	0.42 (0.2)	0.45 (0.2)

Adverse Events

Arm/Group Title	SN60AT		SN60WF
Arm/Group Description	Implantation with the AcrySof Intraocular Lens Model SN60AT		Implantation with the AcrySof Intraocular Lens Model SN60WF
All Cause Mortality
	SN60AT		SN60WF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SN60AT		SN60WF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	SN60AT		SN60WF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publications relating to the study should not be made without the Sponsor's prior written consent and not prior to the completion of the study. The sponsor shall be notified in writing at least 60 days prior to submission of any intention on the part of the Investigator to publish and shall provide the sponsor an opportunity to comment on any proposed publications.