Efficacy of Pilocarpine 1% in Presbyopia

Presbyopia Clinical Trial

Official title:

Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05578001
• Other study ID #: IR.MUI.MED.REC.1401.184
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: October 2022
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: March 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia
• Pseudophakia

Intervention

Drug:
• Pilocarpine Ophthalmic
1 drop of Pilocarpine 1%

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan Eye Research Center	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Near Visual Acuity	Comparison of the BCNVA before and after instillation of Pilocarpine 1%	20 minutes
Secondary	Best Corrected Distance Visual Acuity	Comparison of the BCDVA before and after instillation of Pilocarpine 1%	20 minutes