Clinical trial NCT02691741: Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)
Official title: Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-02-25
Enrollment: 215
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Detailed description: Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of bilateral cataracts with planned clear cornea cataract removal;
* Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
* Calculated lens power between 13.0 and 30.0 Diopters (D);
* Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye;
* Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial;
* Preoperative regular corneal astigmatism of \< 1.00 D, in both eyes;
* Clear intraocular media other than cataract in both eyes;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);
* Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
* Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
* Amblyopia;
* Previous corneal transplant;
* Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction;
* Rubella, congenital, traumatic, or complicated cataracts;
* Glaucoma (uncontrolled or controlled with medication);
* Degenerative eye disorders;
* History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy;
* Optic nerve atrophy;
* Expected to require retinal laser treatment;
* Color vision deficiencies;
* Pregnant or lactating (current or planned during the course of the study);
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
Secondary outcomes:
measure: Least Squares Mean Binocular UCIVA (60cm) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mean Photopic Binocular Defocus Curve at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180
timeFrame: Day 120-180 from second eye implantation
measure: Subject Satisfaction Recorded at Day 120-180
timeFrame: Day 120-180 from second eye implantation
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, a Novartis Company
name: Sr. Clinical Manager, GCRA
role: STUDY_DIRECTOR
References: