NCT03320473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.5 years

First QC Date

October 22, 2017

Last Update Submit

May 9, 2023

Conditions

CataractPresbyopia

Outcome Measures

Primary Outcomes (1)

  • BCDVA

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

    3 months

Secondary Outcomes (1)

  • UCNVA

    3 months

Study Arms (1)

IC-8 IOL

EXPERIMENTAL

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

Device: IC-8 IOL

Interventions

IC-8 IOLDEVICE

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.

IC-8 IOL

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Eye Institute

Makati City, 1200, Philippines

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Nicholas Tarantino, OD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2017

First Posted

October 25, 2017

Study Start

December 5, 2017

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

PH(1)