A Phase 3 interventional study of Pilocarpine Ophthalmic in Presbyopia and Pseudophakia, sponsored by Isfahan University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Isfahan University of Medical Sciences · Phase 3, Interventional, and Supportive care
In this before-after interventional study on patients with presbyopia after cataract surgery, uncorrected distance vision and corrected distance visual acuity are measured and recorded by Snellen chart. Corrected near visual acuity from a distance of 40 cm is measured by the standard near vision chart (Rosenbaum near vision card). Twenty minutes after the administration of pilocarpine 1%, the corrected near and far visual acuity is measured again. Also, the relationship between the difference in average near visual acuity after the administration of 1% pilocarpine in pseudophakic people is measured with iris color and pupil size.
After selecting the study cases, the pupil size in both photopic and scotopic conditions and iris color(based on Simionescu's classification) will be recorded. Uncorrected distance visual acuity(UCDVA) will be measured by Snellen chart. Then the appropriate glasses will be placed according to the person's refraction and the corrected distance visual acuity(BCDVA) will be measured. Without changing the fitted glasses, corrected near visual acuity(BCNVA) is measured from a distance of 40 cm by the standard near vision chart (Rosenbaum near vision card). After this stage, one drop of pilocarpine 1% is prescribed in the patient's eye and 20 minutes later, the corrected near and far visual acuity is measured again. Thirty minutes and 8 hours after the administration of pilocarpine drop, the side effects of the drug, including headache, eye pain, eye redness, eye irritation, tearing, and blurred vision at night, are checked.
336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.
This study's planned enrollment of 25 is below the median of 61 across 276 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Isfahan University of Medical Sciences is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
1 drop of Pilocarpine 1% instill in the eye
Drug: Pilocarpine Ophthalmic
1 drop of Pilocarpine 1%
Also known as: Glaupin 1%
Best Corrected Near Visual Acuity
Comparison of the BCNVA before and after instillation of Pilocarpine 1%
Time frame: 20 minutes
Best Corrected Distance Visual Acuity
Comparison of the BCDVA before and after instillation of Pilocarpine 1%
Time frame: 20 minutes
Started Jul 2022 (actual). Primary completion is estimated for Dec 2022, 5 months after the start.
Of 19 phase 3 interventional studies under Presbyopia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 11. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2022. 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.
Isfahan University of Medical Sciences →