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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760487
• Other study ID #: ALCONsurtor001.06
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2008
• Last updated: January 12, 2012
• Start date: October 2006

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof Toric IOL
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity (VA)	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).	Pre-operative, 1 month, 3 month, and 6 month post-operative	Yes
Secondary	Spectacle Independence	Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit	6 months post-operative	Yes
Secondary	IOL Rotation	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.	6 months post-operative	No