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Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas

Primary Purpose

Cataract, Presbyopia, Irregular Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IC-8 Intraocular Lens (IOL)
Sponsored by
AcuFocus, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Asian Eye InstituteRecruiting
  • Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IC-8 IOL Group

Arm Description

A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye.

Outcomes

Primary Outcome Measures

Monocular uncorrected distance visual acuity (UCDVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected intermediate visual acuity (UCIVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected near visual acuity (UCNVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye
Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR

Secondary Outcome Measures

Monocular and Binocular Contrast Sensitivity
Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing.

Full Information

First Posted
October 7, 2022
Last Updated
December 6, 2022
Sponsor
AcuFocus, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05574270
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
January 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcuFocus, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Presbyopia, Irregular Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IC-8 IOL Group
Arm Type
Experimental
Arm Description
A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye.
Intervention Type
Device
Intervention Name(s)
IC-8 Intraocular Lens (IOL)
Other Intervention Name(s)
IC-8 IOL
Intervention Description
A small aperture extended depth of focus hydrophobic acrylic intraocular lens.
Primary Outcome Measure Information:
Title
Monocular uncorrected distance visual acuity (UCDVA)
Description
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Time Frame
4-6 Months
Title
Monocular uncorrected intermediate visual acuity (UCIVA)
Description
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Time Frame
4-6 Months
Title
Monocular uncorrected near visual acuity (UCNVA)
Description
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Time Frame
4-6 Months
Title
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye
Description
Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR
Time Frame
4-6 Months
Secondary Outcome Measure Information:
Title
Monocular and Binocular Contrast Sensitivity
Description
Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing.
Time Frame
4-6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Minimum 22 years of age; Able to comprehend and have signed a statement of informed consent; Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s); Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation; Planned cataract removal or planned clear lens exchange in both eyes Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal; Having complex corneas with irregular astigmatism Having clear central cornea 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: Requiring an IC-8 IOL outside the available spherical power range; Pharmacologically dilated pupil size less than 6 mm in either eye; Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL; Active or recurrent anterior segment pathology; Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol; Congenital bilateral cataracts; Previous ocular surgery as specified by the protocol; Conditions requiring planned ocular surgical intervention; 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; Use of systemic or ocular medications as specified by the protocol; Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit; Patient is pregnant or nursing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Schall
Phone
336-306-0587
Email
lschall@acufocus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Michna, Ph.D.
Organizational Affiliation
AcuFocus, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Asian Eye Institute
City
Makati City
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Ang, M.D.
Phone
(02) 8-898-2020
Facility Name
Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodhbir Mehta, MBBS, FRCOphth
Phone
(65) 6576 7200

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas

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