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Efficacy of Pilocarpine 1% in Presbyopia

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05578001
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
8.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pilocarpine Ophthalmic
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pilocarpine

1 drop of Pilocarpine 1% instill in the eye

Drug: Pilocarpine Ophthalmic
1 drop of Pilocarpine 1%
Other Names:
  • Glaupin 1%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Best Corrected Near Visual Acuity [20 minutes]

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

    Secondary Outcome Measures

    1. Best Corrected Distance Visual Acuity [20 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Isfahan Eye Research Center Isfahan Iran, Islamic Republic of 81746-73461

    Sponsors and Collaborators

    • Isfahan University of Medical Sciences

    Investigators

    • Study Chair: Alireza Peyman, M.D., Isfahan University of Medical Sciences, Isfahan, Iran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alireza Peyman, Dr. Alireza Peyman, Isfahan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05578001
    Other Study ID Numbers:
    • IR.MUI.MED.REC.1401.184
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 13, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alireza Peyman, Dr. Alireza Peyman, Isfahan University of Medical Sciences
    Pilocarpine
    Presbyopia
    Pseudophakia
    Additional relevant MeSH terms:
    Presbyopia
    Pseudophakia
    Pilocarpine

    Study Results

    No Results Posted as of Oct 13, 2022