Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00760487
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof Toric IOL	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AcrySof Toric IOL AcrySof Toric Intraocular Lens (IOL)	Device: AcrySof Toric IOL; Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

Outcome Measures

Primary Outcome Measures

1. Visual Acuity (VA) [Pre-operative, 1 month, 3 month, and 6 month post-operative]

   Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

Secondary Outcome Measures

1. Spectacle Independence [6 months post-operative]

   Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit

2. IOL Rotation [6 months post-operative]

   Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Are a candidate for bilateral implantation

• In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes

• In need of spherical correction between 10.0 Diopter (D) and 30.0 D

• Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry

• Willing and able to complete all required postoperative visits

• Able to comprehend and sign a statement of informed consent

• Pupil dilation ≥ 6.0 mm

• Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

Exclusion Criteria:

Exclusion Criteria Before Surgery - Ocular

• Previous cataract patient without potential of bilateral implantation

• Females of child bearing potential

• Irregular corneal astigmatism

• Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana

• Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis

• Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)

• Clinically significant corneal dystrophy (including Fuch's dystrophy)

• Previous corneal transplant

• Amblyopia

• Glaucoma (medically uncontrolled)

• Clinically significant RPE/Macular changes

• Proliferative diabetic retinopathy

• History of macular edema

• Previous history of retinal detachment

• History of uveitis/iritis

• Extremely shallow anterior chamber, not due to swollen cataract

• Iris neovascularization

• Microphthalmos

• Absent eye or eye with no light perception (NLP) as fellow eye

• Rubella, congenital, traumatic, or complicated cataract

• Optic atrophy

Exclusion Criteria During Surgery

• Other procedures at this surgery

• Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT, for the duration of the study

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.

• ClinicalTrials.gov Identifier: NCT00760487
• Other Study ID Numbers: ALCONsurtor001.06
• First Posted: Sep 26, 2008
• Last Update Posted: Jan 16, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by , ,: Cataract AcrySof Toric IOL; Bilateral cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects >21 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment Detail	Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.

Arm/Group Title	AcrySof Toric IOL
Arm/Group Description	Implantation of the AcrySof Toric Intraocular lens (IOL)
Period Title: Overall Study
STARTED	120
COMPLETED	117
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	AcrySof Toric IOL
Arm/Group Description	Implantation of the AcrySof Toric Intraocular lens (IOL)
Overall Participants	120
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	77 64.2%
>=65 years	43 35.8%
Sex: Female, Male (Count of Participants)
Female	79 65.8%
Male	41 34.2%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity (VA)
Description	Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Time Frame	Pre-operative, 1 month, 3 month, and 6 month post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AcrySof Toric IOL
Arm/Group Description	Implantation of the AcrySof Toric Intraocular lens (IOL)
Measure Participants	117
Pre-Operative	0.7 (0.06)
1 Day Post-operative	0.06 (0.12)
3 Months Post-operative	0.05 (0.11)
6 Months Post-operative	0.05 (0.11)

2. Secondary Outcome

Title	Spectacle Independence
Description	Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
Time Frame	6 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AcrySof Toric IOL
Arm/Group Description	Implantation of the AcrySof Toric Intraocular lens (IOL)
Measure Participants	117
Number [Percentage of participants]	69 57.5%

3. Secondary Outcome

Title	IOL Rotation
Description	Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.
Time Frame	6 months post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AcrySof Toric IOL
Arm/Group Description	Implantation of the AcrySof Toric Intraocular lens (IOL)
Measure Participants	117
Less than or equal to 5 degrees	91 75.8%
Less than or equal to 10 degrees	99 82.5%

Adverse Events

Arm/Group Title	AcrySof Toric IOL
Arm/Group Description	Implantation of the AcrySof Toric Intraocular lens (IOL)
All Cause Mortality
	AcrySof Toric IOL
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AcrySof Toric IOL
	Affected / at Risk (%)	# Events
Total	0/120 (0%)
Other (Not Including Serious) Adverse Events
	AcrySof Toric IOL
	Affected / at Risk (%)	# Events
Total	1/120 (0.8%)
Surgical and medical procedures
Lens Repositioning	1/120 (0.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.