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

NCT ID: NCT05113979

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2022-09-09

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.

Detailed Description

This will be a 12-month study in which a maximum of 10 pseudophakic patients from three clinical sites will be enrolled. All enrolled subjects will receive an AccuraSee IOPCL with +3.0D add to correct residual refractive errors identified after cataract surgery.

The primary objective of this study is to determine the stability of the AccuraSee IOPCL to successfully adhere to a pseudophakic intraocular lens (PCIOL) without rotation or slippage.

The secondary objective of this study is to determine if the AccuraSee IOPCL can successfully correct refractive errors in subjects previously implanted with a Bausch and Lomb LI61AO and LI61SE monofocal intraocular lens.

Conditions

Refractive Errors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOPCL

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

Group Type: EXPERIMENTAL

AccuraSee IOPCL with +3.0D add

Intervention Type: 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.

Interventions

AccuraSee IOPCL with +3.0D add

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Uncontrolled glaucoma.
• Aniridia.
• Optic nerve atrophy.
• Damaged or incomplete zonules.
• Known history of pseudoexfoliation.
• Medications that, in the opinion of the investigator, may confound the outcome or increase the risk to the subject (tamsulosin hydrochloride (Flomax)) or other medications with similar side effects (floppy iris syndrome).

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OnPoint Vision Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Vision Institute

Bloomington, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol: Clinical Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed consent document

View Document

Other Identifiers

CIIPCL-018

Identifier Type: -

Identifier Source: org_study_id