Efficacy of Pilocarpine 1% in Presbyopia

Isfahan University of Medical Sciences

Status and phase: Active, not recruiting; Phase 3

Conditions: Pseudophakia; Presbyopia

Treatments: Drug: Pilocarpine Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT05578001

IR.MUI.MED.REC.1401.184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Pilocarpine

Experimental group

Description:

1 drop of Pilocarpine 1% instill in the eye

Treatment:

Drug: Pilocarpine Ophthalmic