NCT05578001

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 10, 2022

Last Update Submit

October 10, 2022

Conditions

Keywords

PilocarpinePresbyopiaPseudophakia

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Near Visual Acuity

    Comparison of the BCNVA before and after instillation of Pilocarpine 1%

    20 minutes

Secondary Outcomes (1)

  • Best Corrected Distance Visual Acuity

    20 minutes

Study Arms (1)

Pilocarpine

EXPERIMENTAL

1 drop of Pilocarpine 1% instill in the eye

Drug: Pilocarpine Ophthalmic

Interventions

1 drop of Pilocarpine 1%

Also known as: Glaupin 1%
Pilocarpine

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan Eye Research Center

Isfahan, 81746-73461, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

PresbyopiaPseudophakia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alireza Peyman, M.D.

    Isfahan University of Medical Sciences, Isfahan, Iran

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Alireza Peyman

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

July 1, 2022

Primary Completion

December 30, 2022

Study Completion

March 30, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations