Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Best Corrected Near Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Pilocarpine
1 drop of Pilocarpine 1% instill in the eye
Intervention: Pilocarpine Ophthalmic (Drug)
Outcomes
Primary Outcomes
Best Corrected Near Visual Acuity
Time Frame: 20 minutes
Comparison of the BCNVA before and after instillation of Pilocarpine 1%
Secondary Outcomes
- Best Corrected Distance Visual Acuity(20 minutes)
Investigators
Alireza Peyman
Dr. Alireza Peyman
Isfahan University of Medical Sciences