Efficacy of Pilocarpine 1% in Presbyopia

NCT ID: NCT05578001

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-03-30

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.

Conditions

Presbyopia; Pseudophakia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pilocarpine

1 drop of Pilocarpine 1% instill in the eye

Group Type: EXPERIMENTAL

Pilocarpine Ophthalmic

Intervention Type: DRUG

1 drop of Pilocarpine 1%

Interventions

Pilocarpine Ophthalmic

1 drop of Pilocarpine 1%

Intervention Type: DRUG

Other Intervention Names

Glaupin 1%

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Alireza Peyman

Dr. Alireza Peyman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alireza Peyman, M.D.

Role: STUDY_CHAIR

Isfahan University of Medical Sciences, Isfahan, Iran

Locations

Isfahan Eye Research Center

Isfahan, , Iran

Countries

Iran

References

Peyman A, Naderi-Lordejani M, Irajpour M, Ghanbarnia MJ, Koosha N, Pourazizi M. Pilocarpine 1% for Improved Near Vision in Pseudophakic Patients. J Ophthalmic Vis Res. 2025 May 19;20:10.18502/jovr.v20.15331. doi: 10.18502/jovr.v20.15331. eCollection 2025.

Reference Type: DERIVED

PMID: 40689127 (View on PubMed)

Other Identifiers

IR.MUI.MED.REC.1401.184

Identifier Type: -

Identifier Source: org_study_id