NCT05578001

Efficacy of Pilocarpine 1% in Presbyopia

Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Presbyopia
• Pseudophakia

Interventions

Type	Name	Description
DRUG	Pilocarpine Ophthalmic	1 drop of Pilocarpine 1%

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-12-30
• Completion: 2023-03-30
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: Iran