An interventional study of Accurasee™ IOPCL in Refractive Surgery and Refractive Error - Myopia, sponsored by OnPoint Vision Inc. Recruiting at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by OnPoint Vision Inc · Not applicable, Interventional, and Treatment
This is a study to evaluate the safety and effectiveness of the AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) to improve near and/or intermediate vision following previous cataract surgery.
The objective of this study is to provide preliminary evidence of the safety and efficacy of the AccuraSee intraocular pseudophakic capsular lens (IOPCL) in qualified subjects previously implanted with an Alcon monofocal intraocular lens model SN60WF, SA60WF, or SA60AT, Johnson and Johnson model ZCB00, or Zeiss model CT LUCIA 602 who desire near vision of 20/32 or better via a myopic shift in the eye to be treated.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 10 is below the median of 76 across 301 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →OnPoint Vision Inc is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All ocular eligibility criteria refer to the study (non-dominant) eye only unless otherwise noted.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Accurasee™ IOPCL
Intraocular pseudophakic capsular lens (IOPCL)
Improvement in uncorrected near visual acuity (UCNVA) at 40 cm/16 inches
Improvement in uncorrected near visual acuity (UCNVA) (at 40 cm/16 inches) at 12 months postoperatively. At least 75% of treated eyes should achieve an uncorrected near visual acuity (UCNVA) of 20/32 or better.
Time frame: 12 months
Improvement in uncorrected intermediate visual acuity (UCIVA) (at 66 cm/26 inches)
Improvement in uncorrected intermediate visual acuity (UCIVA) at 66 cm/26 inches at 12 months postoperatively. At least 75% of treated eyes should achieve a UCIVA of 20/40 or better.
Time frame: 12 months
Preservation of best corrected distance visual acuity (BCDVA)
Proportion of eyes (\< 5%) that lose two or more lines of best corrected distance visual acuity (BCDVA) (≥ 10 letters on the Early Treatment for Diabetic Retinopathy Study \[ETDRS\] chart).
Time frame: 12 Months
Successful delivery of the intraocular pseudophakic capsular lens (IOPCL)
Successful delivery of the intraocular pseudophakic capsular lens (IOPCL) (defined as no capsular tear, no visible damage to either the posterior chamber intraocular lens \[PCIOL\] or the IOPCL, and adequate leaflet coverage of all IOPCL haptic tabs \[≥ 0.5 mm of anterior leaflet of capsule above where the haptics reside\]).
Time frame: Postoperatively from 7-14 days visit through 12 months visit
PCIOL Long-term adherence and positional stability (tilt)
Minimal tilt of the posterior chamber intraocular lens (PCIOL) confirmed via Anterion® AS-OCT (defined as ≤ 10 degrees between the postoperative tilt of the PCIOL and the pre-operative tilt of the PCIOL).
Time frame: Postoperatively from 30-60 days visit through 12 months visit
Intraocular Pseudophakic Capsular Lens (IOPCL) Long-term adherence and positional stability (tilt)
Minimal tilt of the intraocular pseudophakic capsular lens (IOPCL) (using the posterior chamber intraocular lens \[PCIOL\] as a reference point) confirmed via Anterion® AS-OCT (defined as ≤ 10 degrees between the post-operative tilt of the PCIOL and the postoperative tilt of the IOPCL).
Time frame: Postoperatively from 30-60 days visit through 12 months visit
PCIOL/IOPCL Complex Long-term adherence and positional stability (decentration)
Decentration of the posterior chamber intraocular lens/intraocular pseudophakic capsular lens (PCIOL/IOPCL complex) (defined as uniform exposed area of the PCIOL outside of the IOPCL at the vertical and horizontal meridians between ≥ 0.5 mm and ≤ 1.0 mm.
Time frame: Postoperatively starting at 7-14 days through 12 months
Intraoperative and postoperative adverse events
Characterization and incidence of cumulative and persistent intraoperative and post-operative adverse events.
Time frame: Intraoperative and Postoperative through 12 months
Secondary Surgical Interventions (SSIs)
Incidence of secondary surgical interventions (SSIs) (e.g., removal of interlenticular opacity, repositioning of intraocular pseudophakic capsular lens \[IOPCL\], explant of IOPCL, repositioning of posterior chamber intraocular lens \[PCIOL\]) (excluding neodymium-doped yttrium aluminum garnet \[Nd:YAG\] treatments for posterior capsule opacification (PCO).
Time frame: Postoperative through 12 months
Endothelial Cell Counts
Endothelial Cell Counts (mean loss, minimum, maximum, and quartiles of endothelial cell density \[ECD\] loss) * Percent of eyes that lose 20% or more ECD * Percent of eyes that lose 25% or more ECD * Percent of eyes that lose 30% or more ECD
Time frame: Postoperatively beginning with 120-180 days through 12 months
Plan to share: No
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