Refractive ErrorsNCT05113979

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

A study testing AccuraSee IOPCL with +3.0D add in people with Refractive Errors, run by OnPoint Vision Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Refractive Errors
What is being tested?: AccuraSee IOPCL with +3.0D add
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2020to 9 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 21Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Chu Vision Institute
Bloomington, Minnesota, 55420

Other trials in United States

About this study

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

Read the 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
Being tested: AccuraSee IOPCL with +3.0D add
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AccuraSee IOPCL with +3.0D addDevice
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.

Study groups in NCT05113979
Study group	Role	What they receive
IOPCL	Experimental	Intraocular Pseudophakic Contact Lens (IOPCL) with +3.0D add Receives: Device: AccuraSee IOPCL with +3.0D add

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20209 Sep 2022

First posted9 Nov 2021
Study start9 Mar 2020
Primary completion9 Sep 2022
Study completion9 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Refractive ErrorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05113979
Sponsor's protocol ID: CIIPCL-018
Status last verified: Apr 2024
First submitted: 4 Aug 2021
Last updated: 25 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
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All Refractive Errors trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05113979
Acronym / sponsor ID: CIIPCL-018
Conditions: Refractive Errors
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: OnPoint Vision IncIndustry (pharma, biotech, devices)
Study start: 9 Mar 2020 (actual)
Primary completion: 9 Sep 2022 (actual)
Study completion: 9 Sep 2022 (actual)
First posted: 9 Nov 2021 (actual)
Results: Posted 25 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
IOPCL	Experimental	Device: AccuraSee IOPCL with +3.0D addIntraocular Pseudophakic Contact Lens (IOPCL) with +3.0D add

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AccuraSee IOPCL with +3.0D addThe 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.	Device	IOPCL

Primary outcome

Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE)
Time frame: 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"
Proportion of subjects (≥ 50%) able to achieve MRSE stability within ±0.5D within two consecutive postoperative visits at 1 month or later visits.
Subjects With Successful Delivery of AccuraSee IOPCL
Time frame: 7-14 days visit
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
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
Time frame: Assessed at 30-60 days visit and 120-180 days visit, 120-180 days visit reported
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.

Results and safety

Results posted to the registry on 25 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intent-to-Treat	10	7

Primary outcome: Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE)

Time frame: 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". Number. Unit: Subjects

Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n = 8
Value	7

Population analysed: All treated subjects with two or more consecutive postoperative visits

Primary outcome: Subjects With Successful Delivery of AccuraSee IOPCL

Time frame: 7-14 days visit. Count of participants. Unit: Participants

Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n = 9
Capsular tear: No	9
Capsular tear: Yes	0
Visualized centration between the PCIOL and IOPCL: No	0
Visualized centration between the PCIOL and IOPCL: Yes	9
Visible damage to either the PCIOL or the IOPCL: No	9
Visible damage to either the PCIOL or the IOPCL: Yes	0
Uniform leaflet coverage of all IOPCL haptic tabs: No	0
Uniform leaflet coverage of all IOPCL haptic tabs: Yes	9

Population analysed: All treated subjects that completed the 7-14 days visit

Primary outcome: 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

Time frame: Assessed at 30-60 days visit and 120-180 days visit, 120-180 days visit reported. Count of participants. Unit: Participants

Measure	Subjects Treated With AccuraSee IOPCL With +3.0D Add n = 8
Gap with less than +/- 10 microns change	8
Gap with greater than +/- 10 microns change	0

Population analysed: All treated subjects that completed the 30-60 days visit and 120-180 days visit.

Adverse events

Time frame: 12-Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intent-to-Treat	2 of 10 (20%)	2 of 10 (20%)	2 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AccuraSee IOPCL with +3.0D add in people with Refractive Errors, run by OnPoint Vision Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With Stable Manifest Refraction Spherical Equivalent (MRSE) (time frame: 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"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05113979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.