IOL Implantation After KAMRA Inlay Removal

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03320473
• Date of registration: 22/10/2017
• Prospective Registration: Yes
• Primary sponsor: AcuFocus, Inc.
• Public title: IOL Implantation After KAMRA Inlay Removal
• Scientific title: A Prospective Study of Small Aperture Intraocular Lens (IOL) Implantation in KAMRA Inlay Patients After Inlay Removal
• Date of first enrolment: December 5, 2017
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03320473
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Philippines

Contacts

• Name: Nicholas Tarantino, OD

Key inclusion & exclusion 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.



Age minimum: 45 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cataract

Presbyopia

Intervention(s)

Device: IC-8 IOL

Primary Outcome(s)

BCDVA [Time Frame: 3 months]

Secondary Outcome(s)

UCNVA [Time Frame: 3 months]

Secondary ID(s)

IC-8 302 KAMR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors