Efficacy of Pilocarpine 1% in Presbyopia | NCT05578001

Studies
Efficacy of Pilocarpine 1% in Presbyopia

NCT05578001

Sponsor

Isfahan University of Medical Sciences

Status

Unknown status

Last Update Posted

Oct 13, 2022Actual

Enrollment

25Estimated

Phase

Phase 3

Conditions

Presbyopia
Pseudophakia

Interventions

Pilocarpine Ophthalmic

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Mar 30, 2023Estimated

First Submitted Date

Oct 10, 2022

First Submission Date that Met QC Criteria

Oct 10, 2022

First Posted Date

Oct 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2022

Last Update Posted Date

Oct 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alireza Peyman, Dr. Alireza Peyman, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pilocarpine	Experimental	1 drop of Pilocarpine 1% instill in the eye	Drug: Pilocarpine Ophthalmic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pilocarpine Ophthalmic	Drug	1 drop of Pilocarpine 1%	Pilocarpine	Glaupin 1%

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alireza Peyman, M.D.	Isfahan University of Medical Sciences, Isfahan, Iran	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isfahan Eye Research Center		Isfahan		81746-73461	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40689127	Derived	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.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011305	Presbyopia
D019591	Pseudophakia