An interventional study of Vision improvement in Hyperopia and Presbyopia, sponsored by VIS, Inc.. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by VIS, Inc. · Not applicable, Interventional, and Treatment
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
156 studies on the registry are indexed under Hyperopia; 20 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 125 interventional studies indexed under Hyperopia.
Browse Hyperopia studies →VIS, Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Subjects who meet all of the following criteria are candidates for this study:
Exclusion Criteria
Subjects who meet any of the following criteria are to be excluded from this study:
nclusion Criteria: -
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Vision improvement
Vision improvement for patients with refractive disorders (hyperopia and presbyopia)
Uncorrected Distance Visual Acuity (UDVA)
Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.
Time frame: Up to 24 months post-treatment
Uncorrected Near Visual Acuity (UNVA)
Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.
Time frame: Up to 24 months post-treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2024; primary completion for Sep 2026, 24 months later.
Of 36 industry-sponsored interventional studies with no phase under Hyperopia, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's planned 24 months is above that.
Counting every sponsor, half of 54 studies reached it within 10 months; a quarter within 4 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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VIS, Inc.