presbyopia
Conditions
Interventions
Control group:0.3% sodium hyaluronate
Experimental group 1:0.75% pilocarpus
Experimental group 2:1.0% pilocarpus
Experimental group 3:1.25% pilocarpus
Sponsors
Eye, Ear, Nose and Throat Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
40 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age: At the time of screening visit, participants must be between 40 and 55 years old (inclusive); 2. Participant type and presbyopia characteristics: Emmetropia or non-emmetropia, the best distance correction for each eye at screening and baseline visit (including -4.00D to + 1.00D under spherical lens, =20/25 in clear vision, medium brightness pupil diameter < 8.0mm in both eyes during screening visit; 3. Gender: No gender limit; 4. Able to give signed informed consent; 5. Others: Able and willing to follow study instructions and likely to complete all required study follow-up as assessed by the investigator.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled systemic disease who have a known allergy or sensitivity to the study intervention or its components or to other cholinergic agonists; 2. Prior/combination treatment: In addition to the study intervention during the study period, concurrent use of any topical ophthalmic medication, including artificial tears, temporary or permanent lacrimal stopper or history of lacrimal cauterization in one or both eyes; 3. Participating in the study drug or device study, or planning to participate in such study within 14 days of participating in the study; 4. The presence of any eye disease (e.g. Uveitis, retinal detachment) that the investigator believes may affect the interpretation of the participant's safety or efficacy parameters; 5. Patients who were pregnant, breastfeeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| distance corrected near visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| distance corrected intermediate visual acuity;pupil diameter at different luminances;pupillary light reflex;adverse event; | — |
Countries
China
Contacts
Public ContactZhou Xingtao
Eye, Ear, Nose and Throat Hospital of Fudan University
Outcome results
None listed