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IOL Implantation After KAMRA Inlay Removal

Primary Purpose

Cataract, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

Philippines

Study Type

Interventional

Intervention

IC-8 IOL

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

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

Inclusion Criteria:

i. Subjects must sign and be given a copy of the informed consent form. ii. Subjects with BCDVA of 20/40 or worse, or significant visual symptoms/complaints as a result of cataract in the study eye.

iii. Subjects must be > 45 years of age at the time of screening. iv. Subjects must be willing and able to return for scheduled follow up examinations for 12 months after surgery.

v. Subjects who underwent uneventful KAMRA inlay implantation and who currently still have the inlay in the eye.

vi. Potential visual acuity following cataract removal and IOL implantation projected to be 0.8 or better (Snellen 20/25) as determined by diagnostic testing or investigator's medical judgment.

Exclusion Criteria:

i. Patients who had any type of intraocular surgery or refractive surgery (with the exception of KAMRA inlay implantation).

ii. Requiring an intraocular lens outside the available power range of +15.5 to +27.5 diopters.

iii. Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos.

iv. Preoperative corneal astigmatism > 1.5 diopters (as determined by corneal topography or keratometry in either eye) or irregular corneal astigmatism.

v. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.8 or worse during the study.

vi. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, etc.).

vii. Glaucoma suspect, uncontrolled ocular hypertension, or history of glaucomatous changes in the retina or visual field.

viii. Subjects with uncontrolled systemic disease. ix. Subjects with previous retinal pathology in either eye.

Sites / Locations

Asian Eye Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IC-8 IOL

Arm Description

IC-8 IOL implantation after removal of KAMRA ACI 7000 PDT inlay

Outcomes

Primary Outcome Measures

BCDVA

Mean monocular best-corrected distance visual acuity at three months is at least 0.3 logMAR

Secondary Outcome Measures

UCNVA

b.1. Mean monocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months is at least 0.3 logMAR.

Full Information

NCT ID

NCT03320473

First Posted

October 22, 2017

Last Updated

May 9, 2023

Sponsor

AcuFocus, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03320473

Brief Title

IOL Implantation After KAMRA Inlay Removal

Official Title

A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 5, 2017 (Actual)

Primary Completion Date

June 20, 2022 (Actual)

Study Completion Date

June 20, 2022 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

A. The primary purpose of the study is to evaluate outcomes of aphakic eyes implanted with the IC-8 IOL following cataract removal in prior inlay patients after KAMRA inlay removal. B. The secondary purpose of the study is to determine whether there are any changes in biometry measurements before and after the inlay removal and how the changes affect the calculated IOL power.

Detailed Description

This will be a prospective study in which no more than 20 subjects will be implanted with IC-8 IOL following the removal of the KAMRA inlay. The refractive target of the IC-8 eye will be -0.75 D MRSE. Subjects will be screened for eligibility and consented before enrolled. Following enrollment, the inlay will be removed, and the eye will be monitored for corneal and refractive stability before the implantation of the IC-8 IOL. Corneal stability is defined as keratometry readings in each meridian within ± 0.50 D, and/or the stability of the corneal topography as determined by the principal investigator, over two consecutive visits at least two weeks apart. Refractive stability is defined as manifest refractive sphere and cylinder measurements that are each within ± 0.50 D over two consecutive visits at least two weeks apart, or based on investigator judgment. When corneal and refractive stability are achieved, the IC-8 IOL will be implanted following cataract extraction by phacoemulsification.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Presbyopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IC-8 IOL

Arm Type

Experimental

Arm Description

IC-8 IOL implantation after removal of KAMRA ACI 7000 PDT inlay

Intervention Type

Device

Intervention Name(s)

IC-8 IOL

Intervention Description

The AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics.

Primary Outcome Measure Information:

Title

BCDVA

Description

Mean monocular best-corrected distance visual acuity at three months is at least 0.3 logMAR

Time Frame

3 months

Secondary Outcome Measure Information:

Title

UCNVA

Description

b.1. Mean monocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months is at least 0.3 logMAR.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: i. Subjects must sign and be given a copy of the informed consent form. ii. Subjects with BCDVA of 20/40 or worse, or significant visual symptoms/complaints as a result of cataract in the study eye. iii. Subjects must be > 45 years of age at the time of screening. iv. Subjects must be willing and able to return for scheduled follow up examinations for 12 months after surgery. v. Subjects who underwent uneventful KAMRA inlay implantation and who currently still have the inlay in the eye. vi. Potential visual acuity following cataract removal and IOL implantation projected to be 0.8 or better (Snellen 20/25) as determined by diagnostic testing or investigator's medical judgment. Exclusion Criteria: i. Patients who had any type of intraocular surgery or refractive surgery (with the exception of KAMRA inlay implantation). ii. Requiring an intraocular lens outside the available power range of +15.5 to +27.5 diopters. iii. Pharmacologically dilated pupil size less than 6 mm or the presence of any pupil abnormalities (aniridia, non-reactive, fixed, or abnormally shaped pupils) or marked microphthalmos. iv. Preoperative corneal astigmatism > 1.5 diopters (as determined by corneal topography or keratometry in either eye) or irregular corneal astigmatism. v. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies, or diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level of 0.8 or worse during the study. vi. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, etc.). vii. Glaucoma suspect, uncontrolled ocular hypertension, or history of glaucomatous changes in the retina or visual field. viii. Subjects with uncontrolled systemic disease. ix. Subjects with previous retinal pathology in either eye.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Tarantino, OD

Official's Role

Study Director

Facility Information:

Facility Name

Asian Eye Institute

City

Makati City

ZIP/Postal Code

1200

Country

Philippines

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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IOL Implantation After KAMRA Inlay Removal

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