Pharmacological Treatment of Presbyopia

Shahid Beheshti University of Medical Sciences

Status and phase: Enrolling; Early Phase 1

Conditions: Near Vision

Treatments: Drug: Pilocarpine 1.25% Eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT05564832

IR.SBMU.ORC.REC.1401.005

Details and patient eligibility

About

In this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. The right eyes of 45 patients will be treated by Biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. In another case group, the right eyes of 30 patients will received Vuity® eye drops and their left eyes will be considered as controls.

Enrollment: 75 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with the best corrected visual acuity (BCVA) better than 0.3LogMAR
• Patients with the symptom of blurred vision at near distance

Exclusion criteria

Patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Pilocarpine Therapy

Experimental group

Description:

The right eyes of 45 patients will be treated by Biocarpine® and Vuity® eye drops. They will be considered as the case group,

Treatment:

Drug: Pilocarpine 1.25% Eye drop

Without Pilocarpine Therapy

No Intervention group

Description:

The left eyes of the patients will be defined as the controls.