Clinical trial NCT05574270: Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
Official title: Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Presbyopia
Irregular Astigmatism
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.

Detailed description: This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated.

The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.

The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.

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 visit(s);
4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;
5. Planned cataract removal or planned clear lens exchange in both eyes
6. Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal;
7. Having complex corneas with irregular astigmatism
8. Having clear central cornea
9. Having best-corrected distance visual acuity (BCDVA) or 20/40 or worse in either eye with or without a glare source (patients with bilateral cataract).

Exclusion Criteria:

1. Requiring an IC-8 IOL outside the available spherical power range;
2. Pharmacologically dilated pupil size less than 6 mm in either eye;
3. Preoperative corneal astigmatism \>1.50 diopters in the eye to be implanted with the IC-8 IOL;
4. Active or recurrent anterior segment pathology;
5. Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol;
6. Congenital bilateral cataracts;
7. Previous ocular surgery as specified by the protocol;
8. Conditions requiring planned ocular surgical intervention;
9. Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication;
10. Use of systemic or ocular medications as specified by the protocol;
11. Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit;
12. Patient is pregnant or nursing.

Primary outcomes:
measure: Monocular uncorrected distance visual acuity (UCDVA)
timeFrame: 4-6 Months
measure: Monocular uncorrected intermediate visual acuity (UCIVA)
timeFrame: 4-6 Months
measure: Monocular uncorrected near visual acuity (UCNVA)
timeFrame: 4-6 Months
measure: Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye
timeFrame: 4-6 Months
Secondary outcomes:
measure: Monocular and Binocular Contrast Sensitivity
timeFrame: 4-6 Months
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
city: Singapore
country: Singapore
facility: Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)
Study officials:
affiliation: AcuFocus, Inc.
name: Magda Michna, Ph.D.
role: STUDY_DIRECTOR
References: