Efficacy of Pilocarpine 1% in Presbyopia

Phase 3

Active, not recruiting

• Conditions: Presbyopia; Pseudophakia
• Interventions: Drug: Pilocarpine Ophthalmic

• Registration Number: NCT05578001
• Lead Sponsor: Isfahan University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2022-12-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Informed consent to participate in the study
• Previous uncomplicated cartaract surgery and PCIOL insertion
• BCDVA eqaul to or more than 8/10
• Less than 1.5 diopter cylindrical refractive error
• Spherical refractive error between -0.5_+1.5
• No history of previous eye disease
• Not using drugs that interact with pilocarpine

Exclusion Criteria

• Occurrence of any drug-related complications
• Unable to follow up the patient after prescribing the drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilocarpine	Pilocarpine Ophthalmic	1 drop of Pilocarpine 1% instill in the eye

Primary Outcome Measures

Name	Time	Method
Best Corrected Near Visual Acuity	20 minutes	Comparison of the BCNVA before and after instillation of Pilocarpine 1%

Secondary Outcome Measures

Name	Time	Method
Best Corrected Distance Visual Acuity	20 minutes	Comparison of the BCDVA before and after instillation of Pilocarpine 1%

Trial Locations

Locations (1)

Isfahan Eye Research Center; 🇮🇷 Isfahan, Iran, Islamic Republic of