Early Feasibility Study to Evaluate the AccuraSee in Correcting Residual Refractive Errors After Cataract Surgery

NCT05113979 | Completed Results

• 1 other identifier: CIIPCL-018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if the intraocular pseudophakic contact lens (IOPCL), referred to as the AccuraSee, corrects residual refractive errors after cataract surgery using a plus powered lens in subjects with ocular pathology previously implanted with a Bausch and Lomb LI61AO or LI61SE monofocal posterior chamber intraocular lens (PCIOL) and to confirm its positional stability and adherence relative to the PCIOL.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (3)

• Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE)

  Proportion of subjects (≥ 50%) able to achieve MRSE stability within ±0.5D within two consecutive postoperative visits at 1 month or later visits.

  Assessed all postoperative consecutive visit pairings beginning with 1 month visit (1 month to 4 months; 4 months to 1 year); reported for "Postoperative period between 1 month and 1 year"

• Subjects With Successful Delivery of AccuraSee IOPCL

  Successful delivery of the AccuraSee IOPCL is defined as: 1) No capsular tear; 2) Visualized centration between the PCIOL and the IOPCL; 3) No visible damage to either the PCIOL or the IOPCL; and 4) Uniform leaflet coverage of all IOPCL haptic tabs

  7-14 days visit

• Long Term Adherence and Positional Stability: Number of Participants With Greater or Less Than +/- 10 Microns Change in Gap Between the Pseudophakic Intraocular Lens and AccuraSee Intraocular Pseudophakic Contact Lens

  Safety Endpoint: Minimal change in uniformity of the gap between the pseudophakic intraocular lens (PCIOL) and AccuraSee intraocular pseudophakic contact lens (IOPCL), between 30-60 days and 120-180 days, as determined by ultrasound biomicroscopy (UBM) measurements. Minimal change is defined as +/- 10 microns.

  Assessed at 30-60 days visit and 120-180 days visit, 120-180 days visit reported

Other Outcomes (1)

• Change in UCDVA From Baseline

  Baseline and 330-420 days

Study Arms (1)

IOPCL

EXPERIMENTAL

Intraocular Pseudophakic Contact Lens (IOPCL) with +3.0D add

Device: AccuraSee IOPCL with +3.0D add

Interventions

AccuraSee IOPCL with +3.0D add DEVICE

The IOPCL (intraocular pseudophakic contact lens) consists of a 4.5mm diameter optic. All subjects will receive a +3.0 power regardless of diopter power based on IOL Master. This IOPCL will be coupled to a Bausch and Lomb Model LI61SE or LI61AO intraocular lens to correct residual refractive errors after cataract surgery.

IOPCL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have already had cataract surgery with a Bausch and Lomb monofocal intraocular lens model LI61AO (with lens power from 18.0 diopters (D) to 23.0 D) or model LI61SE monofocal intraocular lens (with a lens power between from18.0 D and 23.0 D), clearly evidenced by photographic documentation with one of the following: (1) patient medical record, (2) clinic chart with labeling attached, (3) surgical record with labeling attached, or (4) patient identification card with make, model, power, and serial number.
• Able to comprehend and sign a statement of informed consent.
• Willing and able to complete all required postoperative visits.
• Subjects who's baseline manifest refraction spherical equivalent (MRSE) is between -0.5D and +3.0D
• Best corrected visual acuity 20/80 or worse.
• Subjects with ≤1.0D 5D of refractive corneal cylinder
• Subjects willing to abstain from pursuing any other surgical vision-correcting procedures for the duration of the study.
• Subject must be at least 22 years or older.

You may not qualify if:

• Subjects who have already had cataract surgery with a Toric or multifocal Intraocular Lens.
• Subjects who have already had cataract surgery with a Bausch and Lomb monofocal intraocular lens model LI61AO (with a lens power below 18.0 D and greater than 23.0 D) or model LI61SE (with a lens power below 18.0 D and greater than 22.5 D).
• Subjects who were treated with an IOL off-label.
• Subjects who have MRSE of less than 1.0 Diopter (+1.0 to -1.0 D) and more than +3.0D
• Subjects who have more than 1.5D of refractive corneal cylinder
• Subjects whose continuous curvilinear capsulorhexis was less than 5mm or more than 6.0 mm in size at the time of IOL surgery.
• Subjects who had cataract surgery less than 6 months from the planned date of the IOPCL surgery.
• Subjects with anterior capsule fibrosis and phimosis that in the opinion of the investigator may confound the outcome or increase the risk to the subject.
• Acute, chronic or uncontrolled systemic or ocular disease that in the opinion of the investigator would increase the operative risk or confound the outcome(s) of the study.
• Any corneal abnormality, other than regular corneal astigmatism that in the opinion of the investigator would confound the outcome(s) of the study.
• Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy).
• Microphthalmos.
• Previous retinal detachment.
• Recurrent severe anterior or posterior segment inflammation of unknown etiology.
• Iris neovascularization.

Sponsors & Collaborators

• OnPoint Vision Inc: lead

Study Sites (1)

Chu Vision Institute

Bloomington, Minnesota, 55420, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Lynne Archer
• Organization: OnPointVision

larcher@onpoint-vision.com

949-749-4170

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with AccuraSee Intraocular Pseudophakic Contact Lens (IOPCL) at least 6-months after cataract surgery with Bausch and Lomb Model LI61A0 and LI61SE

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: November 9, 2021
• Study Start: March 9, 2020
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)