Clinical trial NCT03633695: Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Official title: Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Keywords: Cataract
Intraocular lens
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 453
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of the IC-8 IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye in accordance with the indication.

Detailed description: Eligible patients will complete up to 12 study visits over a 12-month period. All subjects will complete a preoperative examination of both eyes to assess study eligibility: operative visit (each eye) and up to 9 postoperative visits (Day 1 - each eye, Week 1 - each eye, Month 1 - each eye or combined, Month 3 - both eyes, Month 6 - both eyes, and Month 12 - both eyes). The first eye must meet specific qualification criteria in order to proceed with IOL implantation in the second eye. The second eye should be implanted within 45 days of the first eye.

Eligibility criteria: Inclusion Criteria:

1. Minimum 22 years of age;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation in both eyes;
5. Cataractous lens changes as demonstrated by best-corrected visual acuity (BCDVA) of 20/40 or worse either with or without a glare source present;
6. Potential for postoperative BCDVA of 20/25 or better in each eye
7. Clear intraocular media, other than cataract.

Exclusion Criteria:

1. Requiring an IC-8 intraocular lens outside the available spherical power range
2. Pharmacologically dilated pupil size less than 6 mm in either eye;
3. Inability to achieve stable keratometric readings for contact lens wearers
4. Irregular astigmatism in either eye;
5. Preoperative corneal astigmatism \> 1.50 diopters in either eye
6. Active or recurrent anterior segment pathology
7. Presence of ocular abnormalities other than cataract as specified in the protocol
8. Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye medication;
9. Congenital cataracts;
10. Previous corneal or intraocular surgery
11. History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
12. Systemic conditions as specified in the protocol;
13. Patient is pregnant, plans to become pregnant, or is lactating
14. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit.

Primary outcomes:
measure: Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes
timeFrame: 3 Months (60-110 days post second eye operative visit)
measure: Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
timeFrame: 12 Months (300-420 days post second eye operative visit)
measure: Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
timeFrame: 12 Months (300-420 days post second eye operative visit)
measure: Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
timeFrame: 12 Months (300-420 days post second eye operative visit)
measure: Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
timeFrame: Through 12 Months (300-420 days post second eye operative visit)
measure: Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
timeFrame: Through 12 Months (300-420 days post second eye operative visit)
measure: Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
timeFrame: Through 12 Months (300-420 days post second eye operative visit)
measure: Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals
timeFrame: Through 12 Months (300-420 days post second eye operative visit)
measure: Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
timeFrame: Through 12 Months (300-420 days post second eye operative visit)
Secondary outcomes:
measure: Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months
timeFrame: 3 Months (60-110 days post second eye operative visit)
measure: Mean Monocular Photopic Contrast Sensitivity Without Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Monocular Photopic Contrast Sensitivity With Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Monocular Mesopic Contrast Sensitivity Without Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Monocular Mesopic Contrast Sensitivity With Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Binocular Photopic Contrast Sensitivity Without Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Binocular Photopic Contrast Sensitivity With Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Binocular Mesopic Contrast Sensitivity Without Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
measure: Mean Binocular Mesopic Contrast Sensitivity With Glare
timeFrame: 6 Months (160-210 days post second eye operative visit)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
state: Arizona
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Los Altos
country: United States
facility: Altos Eye Physicians
state: California
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
city: Fort Collins
country: United States
facility: Eye Center of Northern Colorado
state: Colorado
city: Panama City
country: United States
facility: Eye Center of North Florida
state: Florida
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Pepose Vision Institute
state: Missouri
city: Omaha
country: United States
facility: Kugler Vision
state: Nebraska
city: Poughkeepsie
country: United States
facility: Alterman, Modi & Wolter
state: New York
city: Greensboro
country: United States
facility: Physicians Protocol
state: North Carolina
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
city: Ogden
country: United States
facility: Utah Eye Centers
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: AcuFocus, Inc.
name: Magda Michna, PhD
role: STUDY_DIRECTOR
References: