NCT06060041ClinicalTrials.gov

IC-8 Apthera IOL New Enrollment Post Approval Study

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Observationnelle435 participants recherchés14 sites1 pays

Catégories

Ophtalmologie100%

Enregistré dans 1 registre

ClinicalTrials.govNCT06060041Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 21 days after the recorded start)First posted 2023-09-29; recorded start 2023-09-08
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 26 other studies in this databaseCounted from the lead sponsor named in the record (Bausch & Lomb Incorporated)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 3 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 14 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration3/5
Registered within 30 days of the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 435 participants (target), run at 14 sites.

How this score is built

Enrolment26/40
435 participants (target)
Site count14/25
14 sites
Country count0/15
Single country
Planned duration9/10
Planned over about 49 months
Sponsor scale5/10
Bausch & Lomb Incorporated has led 26 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Affections

Presbyopia
Posterior Capsule Opacification
Cataract

Éligibilité

Éligibilité
Sexe	Tous
Âges	22 Years – Aucun maximum
Volontaires sains	Non
Méthode d'échantillonnage	NON_PROBABILITY_SAMPLE

Population de l'étude

Potential study subjects will be recruited from patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification in the IC-8 Apthera IOL eye which requires treatment with Nd:YAG laser capsulotomy

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * 22 years of age or older, any race and any gender; * Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye * Able to comprehend and have signed a statement of informed consent; * Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; * Clear intraocular media in both eyes; * Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation; * Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL. Exclusion Criteria: * Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye; * Irregular astigmatism in either eye; * History of retinal disease; * Active or recurrent anterior segment pathology; * Presence of ocular abnormalities; * Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment; * Previous corneal or intraocular surgery, except cataract surgery; * History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention; * Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study; * Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye; * Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study. * Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Observationnelle
Phase	Non précisé dans la fiche du registre
Répartition	Non précisé dans la fiche du registre
Modèle d'intervention	Non précisé dans la fiche du registre
Objectif principal	Non précisé dans la fiche du registre
Insu	Non précisé dans la fiche du registre
Recrutement	435 participants recherchés

Promoteur et collaborateurs

Bausch & Lomb Incorporated Promoteur

Groupes et interventions

IC-8 Apthera intraocular lens (IOL) Group
Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Critères de jugement

Critère de jugement principal
Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
Rates of additional Nd:YAG laser treatments in the eye implanted with the IC-8 Apthera intraocular lens (IOL) beyond the initial Nd:YAG laser treatment will be assessed through 24 months post IC-8 Apthera IOL implantation
Délai 24 Months post IC-8 Apthera IOL Implantation
Critère de jugement principal
Nd:YAG laser treatment outcome and/or complications
Nd:YAG laser treatment outcomes and/or complications in the eye implanted with the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation.
Délai 24 Months post IC-8 Apthera IOL Implantation
Critère de jugement principal
IOL related assessments
The appearance of the IC-8 Apthera intraocular lens (IOL) will be assessed through 24 months post IC-8 Apthera IOL implantation
Délai 24 Months post IC-8 Apthera IOL implantation
Critère de jugement principal
Rates of Secondary Surgical Interventions (SSIs)
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be assessed through 24 months post IC-8 Apthera IOL implantation
Délai 24 Months post IC-8 Apthera IOL implantation
Critère de jugement principal
Rates of other serious adverse events
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Délai 24 Months post IC-8 Apthera IOL implantation
Critère de jugement principal
Rates of ocular adverse events
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes and fellow eyes will be evaluated through 24 months post IC-8 Apthera IOL implantation
Délai 24 Months post IC-8 Apthera IOL implantation
Critère de jugement principal
Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire
Subjective responses to the QoV Questionnaire that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Délai 24 Months post IC-8 Apthera IOL implantation
Critère de jugement principal
Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)
Subjective responses to the Small Aperture Patient Questionnaire (SAPQ) that assess frequency of visual disturbances (from 'never' to 'very often'), severity of those disturbances (from 'not at all' to 'severe') and bothersomeness of those disturbances (from 'not at all' to 'very') in both the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes.
Délai 24 Months post IC-8 Apthera IOL implantation
Autre critère de jugement
Nd:YAG laser technique details and/or settings
Nd:YAG laser technique and/or settings during treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated
Délai PCO treatment visit (during the Nd:YAG laser procedure)
Autre critère de jugement
Investigator opinion of ease of YAG procedure
Difficulty performing Nd:YAG laser treatment in an IC-8 Apthera intraocular lens (IOL) eye will be evaluated per scale of difficulty chosen by investigator from 'No difficulty' to 'Great difficulty'
Délai PCO treatment visit (during the Nd:YAG laser procedure)
Autre critère de jugement
Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)
Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes (same units of measure for all measurements)
Délai 24 Months post IC-8 Apthera IOL implantation
Autre critère de jugement
Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA)
Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA) will be evaluated in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes (same units of measure for all measurements)
Délai 24 Months post IC-8 Apthera IOL implantation
Autre critère de jugement
Rates of device deficiencies
Rates of device deficiencies in the IC-8 Apthera intraocular lens (IOL) eyes and the fellow eyes will be evaluated
Délai 24 Months post IC-8 Apthera IOL implantation
Autre critère de jugement
Rates of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA)
The rates of each event of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA) between a study visit and a later study visit, the reason for the visual acuity loss, and the treatment/outcome of these instances will be assessed through 24 months post IC-8 Apthera intraocular lens (IOL) implantation
Délai 24 Months post IC-8 Apthera IOL implantation

Dates

Dates
Date de début	8 septembre 2023 (réelle)
Achèvement principal	30 septembre 2027 (estimée)
Achèvement	30 septembre 2027 (estimée)
Première publication	29 septembre 2023 (réelle)
Dernière mise à jour	12 janvier 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	janvier 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

14 sites sont en recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Ophthalmic Partners, PC	Bala-Cynwyd	Pennsylvania	En recrutement
Oakland Eye	Birmingham	Michigan	En recrutement
Utah Eye Centers	Bountiful	Utah	En recrutement
Argus Research Center	Cape Coral	Florida	En recrutement
Trinity Research Group, LLC	Dothan	Alabama	En recrutement
Eye Associates of New Jersey	Dover	New Jersey	En recrutement
Price Vision Group	Indianapolis	Indiana	En recrutement
Feinerman Vision Center	Newport Beach	California	En recrutement
Vance Thompson Vision - Omaha	Omaha	Nebraska	En recrutement
Virdi Eye Clinic and Laser Vision Center	Rock Island	Illinois	En recrutement
Northern New Jersey Eye Institute	South Orange	New Jersey	En recrutement
Berkeley Eye Center	Sugar Land	Texas	En recrutement
Stephenson Eye Associates	Venice	Florida	En recrutement
Grene Vision Group	Wichita	Kansas	En recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06060041