Rotational Stability of the AcrySof® Toric

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00762216
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof® Toric intraocular lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rotational Stability of the AcrySof® Toric
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Toric Implantation with the AcrySof® Toric intraocular lens	Device: AcrySof® Toric intraocular lens; Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery

Outcome Measures

Primary Outcome Measures

1. Rotational Stability [6 Months post-surgery]

   Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

Secondary Outcome Measures

1. Residual Refractive Cylinder [6 Months post-surgery]

   The refractive astigmatism 6 months post-surgery, measured in diopters.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Monolateral or bilateral cataracts

• anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D

• 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings

• able to sign the informed consent, to comply with scheduled visits and other study procedures

Exclusion Criteria:

• Preoperative ocular pathology

• previous intraocular or corneal surgery

• an increased risk for complications which could require vitreoretinal surgery

• corneal irregularities

• corneal opacities

• current contact lens usage

• uncontrolled diabetes

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: NCT00762216
• Other Study ID Numbers: RM-08-001
• First Posted: Sep 30, 2008
• Last Update Posted: Oct 31, 2012
• Last Verified: May 1, 2010

• Keywords provided by Alcon Research: Cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements
Pre-assignment Detail	non-randomized

Arm/Group Title	Toric
Arm/Group Description	Implantation with the AcrySof® Toric intraocular lens
Period Title: Overall Study
STARTED	71
COMPLETED	71
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Toric
Arm/Group Description	Implantation with the AcrySof® Toric intraocular lens
Overall Participants	71
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	38 53.5%
>=65 years	33 46.5%
Sex: Female, Male (Count of Participants)
Female	33 46.5%
Male	38 53.5%

Outcome Measures

1. Primary Outcome

Title	Rotational Stability
Description	Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.
Time Frame	6 Months post-surgery

Outcome Measure Data

Analysis Population Description

67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.

Arm/Group Title	Toric
Arm/Group Description	Implantation with the AcrySof® Toric intraocular lens
Measure Participants	67
Mean (Standard Error) [degrees]	4 (3)

2. Secondary Outcome

Title	Residual Refractive Cylinder
Description	The refractive astigmatism 6 months post-surgery, measured in diopters.
Time Frame	6 Months post-surgery

Outcome Measure Data

Analysis Population Description

69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.

Arm/Group Title	Toric
Arm/Group Description	Implantation with the AcrySof® Toric intraocular lens
Measure Participants	69
Mean (Standard Error) [diopters]	0.4 (0.4)

Adverse Events

Adverse Event Reporting Description	No adverse events were reported for the 71 patients participating in the study.
Arm/Group Title	Toric
Arm/Group Description	Implantation with the AcrySof® Toric intraocular lens
All Cause Mortality
	Toric
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Toric
	Affected / at Risk (%)	# Events
Total	0/71 (0%)
Other (Not Including Serious) Adverse Events
	Toric
	Affected / at Risk (%)	# Events
Total	0/71 (0%)

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.