Efficacy of Pilocarpine 1% in Presbyopia

Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Presbyopia; Pseudophakia
• Intervention / Treatment: Drug: Pilocarpine Ophthalmic

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 81746-73461
    • Isfahan Eye Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilocarpine; 1 drop of Pilocarpine 1% instill in the eye	Drug: Pilocarpine Ophthalmic; 1 drop of Pilocarpine 1%; Other Names: Glaupin 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Near Visual Acuity	Comparison of the BCNVA before and after instillation of Pilocarpine 1%	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Distance Visual Acuity	Comparison of the BCDVA before and after instillation of Pilocarpine 1%	20 minutes

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Study Chair: Alireza Peyman, M.D., Isfahan University of Medical Sciences, Isfahan, Iran

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Presbyopia; Pilocarpine; Pseudophakia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Pseudophakia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: IR.MUI.MED.REC.1401.184

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No