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

Refractive Errors Clinical Trial

Official title:

Early Feasibility Study to Evaluate the Safety and Effectiveness of the AccuraSee for Secondary Implantation in the Capsular Bag to Correct Residual Refractive Errors of Previous Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113979
• Other study ID #: CIIPCL-018
• Status: Completed
• Start date: March 9, 2020
• Est. completion date: September 9, 2022

Study information

• Verified date: April 2024
• Source: OnPoint Vision Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cataract
• Refractive Errors

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Chu Vision Institute	Bloomington	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
OnPoint Vision Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in UCDVA From Baseline	Change in Uncorrected Distance Visual Acuity (UCDVA) from Baseline measured in lines (5 letters) on ETDRS (Early Treatment Diabetic Retinopathy Study)	Baseline and 330-420 days
Primary	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"
Primary	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
Primary	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