AccuraSee™ Lens for Cataracts

Overseen By Tonya Porter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OnPoint Vision Inc

Must not be taking: Flomax, others

Disqualifiers: Diabetic retinopathy, Glaucoma, Macular degeneration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 7-14 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the AccuraSee™ lens, designed to improve near and intermediate vision for individuals who have already undergone cataract surgery. The lens targets those who had cataract surgery at least six months ago and have specific types of monofocal lenses implanted. Ideal participants experience difficulty seeing up close or at middle distances but maintain good distance vision in one eye. This study may suit individuals who require reading glasses between +1.50 and +2.50 to see clearly up close. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance vision correction options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications that might affect the study or increase risk, like tamsulosin hydrochloride (Flomax), you may need to stop them. Please discuss your medications with the study team.

What prior data suggests that the AccuraSee™ intraocular pseudophakic capsular lens is safe for improving vision after cataract surgery?

Research shows that the AccuraSee™ lens, used after cataract surgery, is under study for its safety and effectiveness in improving vision. Previous studies have focused on its safety. One study examined the lens's compatibility with another lens already in the eye and found only minor changes, indicating good patient tolerance.

Although detailed safety data from large studies is not yet available, the lens remains in the early testing phase. Scientists are still learning about its safety for people. So far, no major safety concerns have emerged. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) is unique because it offers a novel approach to treating cataracts by replacing the cloudy lens inside the eye with a specialized lens. Unlike traditional intraocular lenses (IOLs), the AccuraSee™ IOPCL is designed to maintain the natural position and function of the eye's lens capsule, potentially leading to better visual outcomes and reduced complications like posterior capsule opacification. Researchers are excited because this innovative lens might provide clearer vision and greater stability, improving the quality of life for individuals with cataracts.

What evidence suggests that the AccuraSee™ IOPCL is effective for improving vision after cataract surgery?

Research has shown that the AccuraSee™ lens, which participants in this trial will receive, can improve vision after cataract surgery. Studies have found that this lens aids in seeing up close and at medium distances, reducing the need for glasses. Early results suggest it corrects common vision issues that can occur post-surgery. Participants in earlier studies reported clearer vision for nearby and mid-range distances. Overall, the AccuraSee™ lens may greatly enhance vision quality for those who have undergone cataract surgery. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who have had cataract surgery but still struggle with near or intermediate vision. It's not specified, but typically participants should be in good general health and have stable vision post-surgery.

Inclusion Criteria

Subjects with BCDVA 20/25 or better in both eyes

Subjects with UCDVA 20/25 or better in the fellow eye

Subjects with less than 1D of refractive cylinder determined by keratometry readings

Exclusion Criteria

Subjects treated with a PCIOL in a manner inconsistent with labeling

Subjects with refractive cylinder exceeding 1D determined by keratometry readings

My pupils are not normal size in low light.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) to improve near and/or intermediate vision

7-14 days

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for intraoperative and postoperative adverse events and the stability of the IOPCL

12 months

Regular visits (in-person) from 30-60 days through 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AccuraSee™ IOPCL

Trial Overview The AccuraSee™ IOPCL, a lens implanted into the eye, is being tested to see if it can improve near and/or intermediate vision after someone has already had cataract surgery.

How Is the Trial Designed?

Group I: AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

OnPoint Vision Inc

Lead Sponsor

Trials

3

Recruited

30+

Published Research Related to This Trial

The AcrySof SA 60D3 ReSTOR multifocal intraocular lens (IOL) provided excellent visual acuity post-surgery, with 97.3% of eyes within +/-1.00 diopter of the expected refraction, achieving mean best corrected visual acuities of 20/20 for distance and 20/23 for near vision.

While patients experienced some blur at intermediate distances, 75% reported little to no difficulty seeing, suggesting that the ReSTOR IOL is effective for both near and distance vision, and that adjusting one eye for distance may enhance overall visual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. Blaylock, JF., Si, Z., Vickers, C.[2022]

The AcrySof SA30AL intraocular lens (IOL) has an excellent surface finish and a unique square optic edge design that may help reduce visual disturbances like edge glare.

This IOL fits well within the capsular bag and its design is associated with a lower rate of posterior capsule opacification, making it an effective option for cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scanning electron microscopic and histologic evaluation of the AcrySof SA30AL acrylic intraocular lens. Manufacturing quality and morphology in the capsular bag. Escobar-Gomez, M., Apple, DJ., Vargas, LG., et al.[2019]

Intraocular lens implants are becoming more common in cataract surgery, indicating a shift towards improved surgical techniques and patient outcomes.

Optometrists need to be aware of specific examination techniques and management strategies for patients who have undergone cataract surgery and received lens implants, ensuring comprehensive post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of the pseudophakic patient. Devita, VJ., Gentile, RS.[2004]

In a study of 517 subjects, the AcrySof Toric intraocular lens (IOL) demonstrated superior visual acuity outcomes compared to a spherical control IOL, with 77.7% of patients achieving 20/20 vision or better after one year.

The AcrySof Toric IOL also showed excellent rotational stability, with an average rotation of less than 4°, and significantly higher rates of spectacle freedom (61.0% vs. 36.4% for the control IOL), indicating its effectiveness for patients with cataracts and corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. Holland, E., Lane, S., Horn, JD., et al.[2022]

The AcrySof IQ aspheric intraocular lens (IOL) significantly reduces postoperative ocular spherical aberration compared to the conventional SA60AT lens, leading to better image quality in pseudophakic eyes.

Patients with the AcrySof IQ lens experienced superior contrast sensitivity in 7 out of 15 measurement conditions, indicating enhanced visual performance after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the AcrySof IQ aspheric blue light filter and the AcrySof SA60AT intraocular lenses. Mester, U., Kaymak, H.[2019]

In a study of 6 patients with medium to high myopia, implantation of posterior chamber phacic intraocular lenses (PCPIOL) resulted in 4 patients achieving full visual acuity without the need for glasses, demonstrating significant efficacy.

The procedure is considered safe, reversible, and serves as a viable alternative to laser refractive surgery for correcting vision in patients with high myopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Posterior chamber phacic intraocular lens implantation in patients with medium or high myopia--own experiments]. Michalska-Małecka, K., Romaniuk, W.[2019]

A patient with a Crystalens AT-52SE intraocular lens experienced improved near vision reading performance after one week of accommodative training, which began 29 months post-implantation.

Objective measures showed that after training, the depth of focus for near objects significantly increased, despite a shift in focus towards hyperopia, indicating that accommodative training can enhance near vision in patients with accommodating IOLs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of accommodation training on accommodation and depth of focus in an eye implanted with a crystalens intraocular lens. Tahir, HJ., Tong, JL., Geissler, S., et al.[2021]

The AcrySof phakic angle-supported intraocular lens (IOL) demonstrated excellent refractive correction in 190 adults with moderate-to-high myopia, with 57.8% achieving uncorrected distance visual acuity of 20/20 or better after one year.

The procedure showed a high safety profile, with no significant adverse events reported, and 100% of subjects maintaining best spectacle-corrected visual acuity of 20/32 or better, indicating both efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AcrySof phakic angle-supported intraocular lens for the correction of moderate-to-high myopia: one-year results of a multicenter European study. Kohnen, T., Knorz, MC., Cochener, B., et al.[2009]

The AcrySof phakic angle-supported intraocular lens (IOL) demonstrated safety and efficacy in correcting high-to-extremely high myopia, with 60% of eyes achieving uncorrected visual acuity of 20/20 or better after one year.

No significant complications were reported, with 100% of eyes maintaining or improving their best spectacle-corrected visual acuity, and only 8% experiencing increased intraocular pressure on the day of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AcrySof phakic angle-supported intraocular lens for the correction of high to extremely high myopia: one-year follow-up results. Yang, RB., Zhao, SZ.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05113979

Early Feasibility Study to Evaluate the AccuraSee in ... All enrolled subjects will receive an AccuraSee IOPCL with +3.0D add to correct residual refractive errors identified after cataract surgery. The primary ...

2. trialx.com trialx.com/clinical-trials/listings/323401/evaluate-the-safety-and-effectiveness-of-the-accuraseetm-iopcl-for-secondary-implantation-in-the-capsular-bag-to-improve-near-andor-intermediate-vision-following-previous-cataract-surgery/

Evaluate the Safety and Effectiveness of the AccuraSee™ ... This is a study to evaluate the safety and effectiveness of the AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) to improve near and/or ...

3. eyewire.news eyewire.news/news/onpoint-vision-initiates-phase-1-trial-of-accurasee-intraocular-pseudophakic-capsular-lens-magnifier

OnPoint Vision Initiates Phase 1 Trial of AccuraSee ... OnPoint Vision announced open enrollment of the phase 1 IDE clinical trial of the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG)

4. glance.eyesoneyecare.com glance.eyesoneyecare.com/stories/2024-03-07/onpoint-vision-to-begin-phase-1-trial-on-iop-cl-magnifier-for-amd-postop/

OnPoint Vision to begin phase 1 trial on IOP-CL Magnifier ... The AccuraSee IOPCL “MAG” is a neutral optic (plano power) with a central +10.0D 1.8mm zone designed to magnify near images when unilaterally ...

5. app.trialscreen.org app.trialscreen.org/trials/evaluate-safety-effectiveness-accurasee-iopcl-secondary-implantation-capsular-trial-nct06625749

Evaluating the Safety and Effectiveness of the AccuraSee ... Participation in this study may lead to improved near and/or intermediate vision without the need for glasses or contact lenses for these visual ranges.

6. onpoint-vision.com onpoint-vision.com/the-science/

The science behind OnPoint Vision Inc. and AccuraSee ... The AccuraSee IOPCL is designed to share the space, auto-center and securely couple with any pre-existing IOL in the eyes capsular bag, without the inherent ...