Emmetropic presbyopes
Conditions
Interventions
None listed
Sponsors
Japanese Research Center of Refractive Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Emmetropic presbyopes who have provided informed consent for ACI implantation, and meet all the following criteria: 1. Emmetropes needing a magnitude of +0.75D to +2.50D of reading glasses 2. Distance visual acuity correctable to at least 0.8 in both eyes 3. Preoperative spherical equivalent of plano defined as +0.50D to -1.25D with no more than 0.75D of refractive cylinder in the eye to be implanted 4. Must discontinue their soft contact lenses for at least one week prior to ACI pre-operative examination 5. Minimum central corneal thickness of >= 500 microns in the eye to be implanted. 6. Corneal power of >= 39.00D and <= 49.00D in all meridians in the eye to be implanted 7. Endothelial cell count >= 2000 cells/mm2 in the eye to be implanted 8. Able to return for scheduled follow-up examinations for 12 months after surgery 9. Written informed consent given.
Exclusion criteria
Exclusion criteria: 1. Active or recurrent ocular pathology, including eyelid disease, corneal abnormalities (e.g. keratoconus, endothelial dystrophy), cataracts, glaucoma, ocular hypertension, macular degeneration, retinal detachment or any other ocular pathology that would prevent an acceptable visual outcome in the eye to be implanted 2. With a history of steroid-responsive rise in intraocular pressure. 3. Dry eye as determined by objective testing. 4. Using systemic medications with significant ocular side effects, including medications known to exacerbate or induce moderate to severe dry eye. 5. Abnormal threshold visual field. 6. With a history of herpes zoster or herpes simplex keratitis. 7. With a history of diagnosed diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome. 8. Chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing, and any immunocompromised patients. 9. Using ophthalmic medication(s) other than artificial tears for treatment of any ocular pathology including ocular allergy. 10. Sensitivity to planned study concomitant medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncollected distance visual acuity and uncollected near visual acuity | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction Safety | — |
Countries
Japan
Contacts
Public ContactHiroshi Morifuji
Mebix, Inc. The 3rd Research Promotion Group
Outcome results
None listed