Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02176343

Enrollment

Registered

2014-06-27

Start date

2014-07-21

Completion date

2014-08-22

Last updated

2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Corneal Astigmatism, Presbyopia

Keywords

Cataract, Intraocular lens, ACRYSOF IQ ReSTOR + 2.5 D Multifocal Toric IOL

Brief summary

The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.

Detailed description

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data, and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation.

Interventions

DEVICEAcrySof® IQ ReSTOR® +2.5 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Must sign an informed consent form and be willing to come in for a visit at least 3 months and not more than 14 months after IOL implantation with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL (Models SV25T2, SV25T3, SV25T4 and SV25T5); * Must be implanted with the correct lens based on preoperative corneal astigmatism as specified in the protocol; * Must complete a visit within 10 days after IOL implantation; * Successful capsular bag implantation with no surgical complications; * Other protocol-specified inclusion criteria may apply.

Exclusion criteria

* IOL implanted prior to the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL; * Ocular or intraocular infection or inflammation at the time of the preoperative visit; * Any ocular surgery or intraocular laser procedure at or prior to the surgical visit; * Any conditions affecting the cornea (eg. corneal dystrophy, severe dry eye) at the preoperative visit; * Retinal conditions (e.g. degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit; * Known history of Type 1 or 2 diabetes for more than 5 years; * Any ocular or systemic co-morbidity at the preoperative visit; * Pregnant at the preoperative visit or at the time of Postoperative Visit 2; * Preoperative corneal astigmatism ≤ 0.50 D; * Participation in another clinical study at the preoperative visit or at the time of the final study visit; * Other protocol-specified

Design outcomes

Primary

Measure	Time frame	Description
Mean Percent Reduction in Cylinder	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder \[defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder\], multiplied by 100%. One eye (primary eye) contributed to the analysis.
Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Mean Uncorrected Distance Visual Acuity	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.
Mean Uncorrected Near Visual Acuity	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in 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. One eye (primary eye) contributed to the analysis.
Mean Uncorrected Intermediate Visual Acuity	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in 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. One eye (primary eye) contributed to the analysis.
Mean Best Corrected Distance Visual Acuity (BCDVA)	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in 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. One eye (primary eye) contributed to the analysis.
Mean IOL Rotation	Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)	Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.

Participant flow

Recruitment details

Subjects were recruited from 4 study centers located in Australia.

Pre-assignment details

Of the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).

Participants by arm

Arm	Count
ReSTOR Toric +2.5 AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL	31
Total	31

Baseline characteristics

Characteristic	ReSTOR Toric +2.5
Age, Continuous	69.2 years STANDARD_DEVIATION 9.5
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	14 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 31
other Total, other adverse events	4 / 31
serious Total, serious adverse events	3 / 31

Outcome results

Primary

Mean Best Corrected Distance Visual Acuity (BCDVA)

VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in 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. One eye (primary eye) contributed to the analysis.