Presbyopia
Conditions
Interventions
Experimental group:Create a corneal pocket using femtosecond laser, then implant and position the investigational device within the pocket.
Sponsors
"Eye Hospital, WMU" & "Eye&ENT Hospital of Fudan University"
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 45–65 years (inclusive), either sex; 2.Confirmed diagnosis of presbyopia with a habitual near-add requirement of +1.50 D to +3.50 D; 3.Uncorrected near visual acuity (UCNVA) = 20/25 in each eye; 5.Best-corrected distance visual acuity (BCDVA) >= 20/25 in each eye; 6.After cycloplegia, spherical equivalent between –0.75 D and +1.00 D with = 450 µm in the non-dominant eye; 8.Endothelial cell count >= 1800 cells/mm^2 in the non-dominant eye; 9.Photopic pupil diameter > 1.6 mm in the non-dominant eye; 10.Contact-lens wearers: discontinue hard/RGP lenses >= 3 weeks and soft lenses >= 1 week before baseline examinations; 11.For hard/RGP lens wearers: (1)Two central keratometry readings with regular mires; (2)Two manifest refractions >= 1 week apart, with keratometric values differing by <= ±0.50 D in any principal meridian of the study eye; 12.Able to communicate with the investigator, understand the study, and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Psychiatric illness precluding cooperation; 2.Pregnant, breast-feeding, or planning pregnancy during the study; 3.Concurrent participation in another drug or device clinical investigation; 4.Inability to determine dominant and non-dominant eyes; 5.Non-dominant eye meeting any of: (1) Amblyopia; (2) Active, recurrent, or uncontrolled ocular disease (e.g., lid disease, severe dry eye); (3) Significant corneal topographic abnormality (keratoconus, corneal dystrophy, central calcification, recurrent erosion, etc.); (4)Pupil abnormality (distortion, non-reactivity, or decentration); (5) Superficial punctate keratitis (SPK) grade > II; 6.Spherical equivalent change > 0.50 D within the past 12 months; 7.Preoperative intraocular pressure (IOP) > 21 mmHg, history of steroid-induced IOP elevation, or glaucoma; 8.Difference in spherical equivalent between manifest and cycloplegic refraction = 1.00 D; 9.Inability to complete or intolerance of monovision trial defined as incomplete satisfaction with vision or debilitating visual symptoms (e.g., glare, halos); 10.Acute or chronic systemic diseases increasing surgical risk or impairing healing (autoimmune disease, connective-tissue disease, uncontrolled diabetes, neoplastic disease); 11.Subjects taking medication for diabetes control; 12.Use of ophthalmic medications other than artificial tears, or systemic therapies that may compromise corneal health or healing (steroids, antimetabolites, chemotherapy, amiodarone, etc.); intranasal steroids for seasonal allergies are permitted; 13.History or presence of acute or chronic ocular disease in either eye, including herpes zoster or herpes simplex keratitis, glaucoma, cataract, diabetic retinopathy, macular degeneration, or peripheral retinal disease; 14.History of severe allergic reactions or hypersensitivity to planned study medications (antibiotics, anti-inflammatory agents, anaesthetics); 15.Investigator considers the subject unsuitable, including those requiring canthotomy for device implantation, or whose occupational demands negate near-vision improvement (occupations with habitual working distance 45 cm, e.g., mariners, long-haul drivers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of uncorrected near visual acuity (UCNVA) at 40 cm in the operated eye at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement rate of uncorrected near visual acuity (UCNVA) at 40 cm in the operated eye postoperatively;Mean gain in uncorrected near visual acuity (UCNVA) at 40 cm in the operated eye from pre-operative to post-operative;Among patients whose preoperative best-corrected near visual acuity (BCNVA) in the operated eye was >=20/20, the proportion achieving postoperative uncorrected near visual acuity (UCNVA) at 40 cm =20/20 in the same eye;Subject satisfaction at 12 months post-procedure; | — |
Countries
China
Contacts
Public ContactQu Jia;Zhou Xingtao
Eye Hospital, WMU & Eye&ENT Hospital of Fudan University"
Outcome results
None listed