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IOL Implantation After KAMRA Inlay Removal

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ClinicalTrials.gov Identifier: NCT03320473
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
AcuFocus, Inc.

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.


Condition or disease Intervention/treatment Phase
Cataract Presbyopia Device: IC-8 IOL Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: IC-8 IOL
IC-8 IOL implantation after removal of KAMRA ACI 7000 PDT inlay
Device: IC-8 IOL
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 Measures :
  1. BCDVA [ Time Frame: 3 months ]
    Mean monocular best-corrected distance visual acuity at three months is at least 0.3 logMAR


Secondary Outcome Measures :
  1. UCNVA [ Time Frame: 3 months ]
    b.1. Mean monocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months is at least 0.3 logMAR.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320473


Contacts
Contact: Nicholas Tarantino, OD 9495859511 ext 106 ntarantino@acufocus.com
Contact: Srividhya Vilupuru, OD, PhD 9495859511 ext 182 svilupuru@acufocus.com

Locations
Philippines
Asian Eye Institute Recruiting
Makati City, Philippines, 1200
Contact: Shiela De Castro    +632 8982020 ext 510    SSDeCastro@asianeyeinstitute.com   
Principal Investigator: Robert Ang, MD         
Sponsors and Collaborators
AcuFocus, Inc.
Investigators
Study Director: Nicholas Tarantino, OD

Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT03320473     History of Changes
Other Study ID Numbers: IC-8 302 KAMR
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors