An observational study in Visual Outcome, sponsored by Hoya Surgical Optics, Inc.. Recruiting at 1 site in Philippines. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Hoya Surgical Optics, Inc. · Observational
This is a prospective, multicenter, parallel groups, non-interventional, examiner masked, comparative clinical study. Patients that participated in previous Hoya studies, and patients previous implanted with Hoya non-toric monofocal IOLs (sub-study only) will be enrolled in the study. The sample size for this study is based on demonstrating the non-inferiority of the mean distance-corrected intermediate visual acuity (DCIVA) in Group 1 (Site 1) compared with Group 2 (Site 2).
Hoya Surgical Optics, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes subjects who have previously undergone intraocular lens implantation in prior studies. Subjects must have clear intraocular media, good visual acuity, and be able to provide informed consent and complete study procedures.
For the exploratory sub-study, a subset of subjects with eyes from multiple prior IOL studies will be included, excluding those with oblique residual astigmatism.
Main study:
Exploratory sub-study:
1. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies
Exclusion Criteria:
Main study:
Exploratory sub-study:
1. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
Evaluate visual outcomes in extension cohort
Other: Non-Interventional Study
Evaluate visual outcomes in extension cohort
Other: Non-Interventional Study
Evaluate visual outcomes in extension cohort
Other: Non-Interventional Study
This clinical investigation is non-interventional and does not involve the use of any new medical device.
Distance-corrected intermediate visual acuity
The primary objective of this study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to distance-corrected intermediate visual acuity (DCIVA), using a predefined non-inferiority margin of 0.10 logMAR.
Time frame: Up to 15 days
Corrected distance visual acuity and distance-corrected near acuity
The secondary objective of the study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to corrected distance visual acuity (CDVA) and distance-corrected near acuity (DCNVA), using a non-inferiority margin of 0.10 logMAR.
Time frame: Up to 15 days
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet 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.
Hoya Surgical Optics, Inc.