A study of the AcuFocus(TM) KAMRA(TM) Corneal Inlay implanted intra-stromally in presbyopic patients

UMIN ID: UMIN000002135

Registered date:29/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: Emmetropic presbyopes
• Date of first enrollment: 2009/06/01
• Target sample size: 1000
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Uncollected distance visual acuity and uncollected near visual acuity
• Secondary Outcome: Patient satisfaction Safety

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Japanese Research Center of Refractive Surgery
• Source(s) of Monetary Support: Japanese Research Center of Refractive Surgery