Efficacy of Pilocarpine 1% in Presbyopia
Primary Purpose
Presbyopia, Pseudophakia
Status
Active
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pilocarpine Ophthalmic
Sponsored by
About this trial
This is an interventional supportive care trial for Presbyopia focused on measuring Pilocarpine, Presbyopia, Pseudophakia
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
Sites / Locations
- Isfahan Eye Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilocarpine
Arm Description
1 drop of Pilocarpine 1% instill in the eye
Outcomes
Primary Outcome Measures
Best Corrected Near Visual Acuity
Comparison of the BCNVA before and after instillation of Pilocarpine 1%
Secondary Outcome Measures
Best Corrected Distance Visual Acuity
Comparison of the BCDVA before and after instillation of Pilocarpine 1%
Full Information
NCT ID
NCT05578001
First Posted
October 10, 2022
Last Updated
October 10, 2022
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05578001
Brief Title
Efficacy of Pilocarpine 1% in Presbyopia
Official Title
Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Pseudophakia
Keywords
Pilocarpine, Presbyopia, Pseudophakia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilocarpine
Arm Type
Experimental
Arm Description
1 drop of Pilocarpine 1% instill in the eye
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Ophthalmic
Other Intervention Name(s)
Glaupin 1%
Intervention Description
1 drop of Pilocarpine 1%
Primary Outcome Measure Information:
Title
Best Corrected Near Visual Acuity
Description
Comparison of the BCNVA before and after instillation of Pilocarpine 1%
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Best Corrected Distance Visual Acuity
Description
Comparison of the BCDVA before and after instillation of Pilocarpine 1%
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Peyman, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
Isfahan Eye Research Center
City
Isfahan
ZIP/Postal Code
81746-73461
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Pilocarpine 1% in Presbyopia
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