An observational study in Cataract and Pseudophakia, sponsored by Vance Thompson Vision. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Vance Thompson Vision · Observational
The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 25 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.
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:
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.
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.
Subjects that underwent standard of care cataract surgery and LAL IOL placement.
Procedure: LAL IOL lens
Standard of care Cataract surgery with IOL placement
Binocular uncorrected distance, intermediate, and near visual acuity
Time frame: Through Month one post-op
Binocular uncorrected depth of focus
Time frame: Through Month one post-op
Manifest refraction
Time frame: Through Month one post-op
Monocular uncorrected distance visual acuity
Time frame: Through Month one post-op
Monocular best corrected distance visual acuity
Time frame: Through Month one post-op
Visual Satisfaction
Visual satisfaction will be obtained using a visual questionnaire
Time frame: Through Month one post-op
4th order total eye spherical aberration (Z12)
Time frame: Through Month one post-op
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Jan 2021, 4 months.
Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 4 months is below that.
Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Vance Thompson Vision