Status:

NOT_YET_RECRUITING

The Development of New Functions of Esculin and Digitalis Glycosides Eye Drops: A Study on the Treatment of Presbyopia

Lead Sponsor:

Yan Gao

Conditions:

Presbyopia

Eligibility:

All Genders

40-55 years

Phase:

PHASE4

Brief Summary

Presbyopia is a condition where the eyes cannot focus a clear image on the retina when looking at nearby objects, commonly seen in people over 40 years old, which has a serious impact on people's dail...

Eligibility Criteria

Inclusion

  • Age is within the range of 40 - 55 years old.
  • After mydriasis, for one eye, the refractive power is within -0.5D - 2.0D and the astigmatism is ≤ 1.0D.
  • When measuring uncorrected visual acuity with a standard logarithmic visual acuity chart, the uncorrected distance visual acuity (UDVA) of both eyes is ≥ 1.25, and the uncorrected near visual acuity (UNVA) is ≤ 0.8.
  • When using a slit lamp to detect cataract development according to the LOCS Ⅲ grading standard, no NO3 - NC3 or more severe lens opacity is detected; and no ocular surface diseases, visual fatigue, or any corneal diseases (such as dry eye, corneal injury, corneal opacity, keratoconus, or having undergone corneal refractive surgery, etc.) are detected.
  • The subject has not used Ginkgo biloba extract dichloride eye drops within 2 weeks; has no known or suspected allergy to digitalis - like drugs; and has not used insulin, anti - anxiety drugs, antidepressants, antipsychotics, antihistamines, antispasmodics, diuretics, etc.

Exclusion

  • Age is not in the range of 40 - 55 years old.
  • After mydriasis, for one eye, the refractive power is higher than 2.0D or lower than -0.5D, or the astigmatism is higher than 1.0D.
  • When measuring the uncorrected distance visual acuity (UDVA) of both eyes with a standard logarithmic visual acuity chart, if the UDVA is lower than 1.25, or the uncorrected near visual acuity (UNVA) is higher than 0.8.
  • When using a slit lamp to detect cataract development according to the LOCS Ⅲ grading standard, NO3 - NC3 or more severe lens opacity is detected in the lens; or ocular surface diseases, visual fatigue, or any corneal diseases (such as dry eye, corneal injury, corneal opacity, keratoconus, or having undergone corneal refractive surgery, etc.) are detected.
  • The subject has used Ginkgo biloba extract dichloride eye drops within 2 weeks; has known or suspected allergy to digitalis - like drugs; or has used insulin, anti - anxiety drugs, antidepressants, antipsychotics, antihistamines, antispasmodics, diuretics, etc.

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT07151612

Start Date

September 1 2025

End Date

November 1 2025

Last Update

September 3 2025

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