Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

Cataract Clinical Trial

Official title:

A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200511
• Other study ID #: M09-052
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Description:

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Sign informed consent;

• Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;

• Able to undergo second eye surgery within one month (30 days) of first eye surgery;

• Able to attend postoperative examinations per protocol schedule;

• Qualify for a AcrySof IQ Toric IOL in both eyes;

• Preoperative astigmatism of =0.75 to =2.5 diopters (D) in both eyes;

• Residual refractive cylinder of =0.5 D in both eyes;

• Good ocular health;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;

• Amblyopia;

• Previous corneal surgery;

• Clinically significant corneal endothelial dystrophy;

• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);

• History of retinal detachment;

• Pregnant or planning to become pregnant during course of study;

• Other protocol-defined exclusion criteria may apply.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Visual Acuity Across a Range of Distances at Month 6	Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.	Month 6 from second eye implantation
Primary	Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6	VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.	Month 6 from second eye implantation
Primary	Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6	Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.	Month 6 from second eye implantation
Secondary	Patient Reported Outcomes at Month 6	The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.	Month 6 from second eye implantation

External Links

•   Results from the Novartis Clinical Trial Results Website