An observational study in Aphakia, Cataract and Clear Lens Exchange, sponsored by Teleon Surgical B.V.. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Teleon Surgical B.V. · Observational
This is a retrospective, observational (Registry) study aiming to collect safety and performance data on the use of intraocular lenses (IOLs) manufactured by Teleon Surgical B.V. according to routine practice.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 2,183 is above the median of 95 across 15 observational studies indexed under Aphakia.
Browse Aphakia studies →Teleon Surgical B.V. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have undergone uni- or bilateral extraction of the crystalline lens by means of phacoemulsification or femtosecond laser-assisted cataract surgery with implantation of the subject IOL.
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.
Exclusion Criteria:
Subjects were implanted with a HydroSmart IOL (FEMTIS, LENTIS or VISIOTIS)
Device: Posterior-chamber intraocular lens
Subjects were implanted with an ACUNEX IOL
Device: Posterior-chamber intraocular lens
Implantation of a posterior-chamber intraocular lens to correct aphakia after removal of the crystalline lens
Visual acuity (uncorrected and/or corrected)
Monocular visual acuity measured under photopic conditions from preoperative to Month 24 using standard methods (e.g. Snellen Chart 6/6-metre, 1.0 decimal or 0.0 logMAR) at standard distances (4 m for far, 65-80 cm for intermediate and 35-40 cm for near distance), depending on IOL optical design, as follows: For monofocal IOLs: • Uncorrected and corrected distance visual acuity For monofocal toric IOLs: * Uncorrected and corrected distance visual acuity * Residual astigmatism * IOL rotation For multifocal IOLs: * Uncorrected and corrected distance visual acuity * Uncorrected and corrected near visual acuity * Uncorrected and corrected intermediate visual acuity, if available For multifocal toric IOLs: * Uncorrected and corrected distance visual acuity * Uncorrected and corrected near visual acuity * Uncorrected and corrected intermediate visual acuity, if available * Residual astigmatism * IOL rotation
Time frame: Preoperatively to Month 24
Adverse events and adverse device effects
Time frame: Usual follow-up: 24 Months
Patient and user satisfaction
Satisfaction of the patient with the outcomes of the procedure/medical device Satisfaction of the user with handling of the medical device and patients outcomes
Time frame: Month 1
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Teleon Surgical B.V.