Clinical trial NCT01424189: Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Official title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Cataract surgery
Intraocular lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 677
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Detailed description: Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with bilateral cataracts;
* Able to comprehend and sign a statement of informed consent;
* Calculated lens power and astigmatism within the available range;
* Willing and able to complete all required postoperative visits;
* Planned cataract removal by phacoemulsification;
* Potential postoperative visual acuity of 0.2 logMAR or better in both eyes;
* Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.
* Clear intraocular media other than cataract in study eyes;
* Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye;
* Pupil size greater than or equal to 6 mm after dilation;
* Able to undergo second eye surgery within 30 days of the first eye surgery;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Significant irregular corneal aberration as demonstrated by corneal topography;
* Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;
* Any inflammation or edema (swelling) of the cornea;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;
* Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);
* Previous corneal refractive surgery;
* Amblyopia;
* Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy);
* Diabetic retinopathy;
* Extremely shallow anterior chamber, not due to swollen cataract;
* Microphthalmos;
* Previous retinal detachment;
* Previous corneal transplant;
* Recurrent severe anterior or posterior segment inflammation of unknown etiology;
* Rubella or traumatic cataract;
* Iris neovascularization;
* Glaucoma (uncontrolled or controlled with medication);
* Aniridia;
* Optic nerve atrophy;
* Pregnancy;
* Current participation in another investigational drug or device study that may confound the results of this investigation;
* Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions, for the duration of the study;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
timeFrame: Month 12 from second eye implantation
measure: Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
timeFrame: Month 12 from second eye implantation
measure: Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
timeFrame: Month 12 from second eye implantation
Secondary outcomes:
measure: Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
timeFrame: Month 12 from second eye implantation
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Expert Clinical Project Lead, GCRA, Surgical
role: STUDY_DIRECTOR
References:
citation: Williams JR, Kim HW, Crespi CM. Modeling observations with a detection limit using a truncated normal distribution with censoring. BMC Med Res Methodol. 2020 Jun 29;20(1):170. doi: 10.1186/s12874-020-01032-9.