Clinical trial NCT05113979: Early Feasibility Study to Evaluate the AccuraSee in Correcting Residual Refractive Errors After Cataract Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Lead sponsor: OnPoint Vision Inc
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Treatment with AccuraSee Intraocular Pseudophakic Contact Lens (IOPCL) at least 6-months after cataract surgery with Bausch and Lomb Model LI61A0 and LI61SE
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE)
timeFrame: 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"
measure: Subjects With Successful Delivery of AccuraSee IOPCL
timeFrame: 7-14 days visit
measure: 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
timeFrame: Assessed at 30-60 days visit and 120-180 days visit, 120-180 days visit reported
Secondary outcomes:
Other outcomes:
measure: Change in UCDVA From Baseline
timeFrame: Baseline and 330-420 days
Locations:
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
Study officials:
References: