NL-OMON35740已完成不适用
A PROSPECTIVE MULTICENTER CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE ACUFOCUS* CORNEAL INLAY ACI 7000PDT IMPLANTED INTRA-STROMALLY FOR MODIFIED MONOVISION IN PRESBYOPIC SUBJECTS - ACU-P10-020B (AcuFocus, ACI 7000PDT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects must sign and be given a copy of the written Informed Consent form.
- •2. Subjects must be emmetropes needing a magnitude of +1.00D to +2.50D of reading
- •3. Subjects must have uncorrected near visual acuity worse than 20/40 and better
- •than 20/100 in the eye to be implanted.
- •4. Subjects must have distance visual acuity correctable to at least 20/20 in both eyes.
- •5. Subjects must have a preoperative spherical equivalent of plano defined as +0.50D to -0.75D with no more than 0.75D of refractive cylinder as determined by cycloplegic refraction in the eye to be implanted.
- •6. Subjects must have a stable refraction twelve months prior to ACI implantation: i.e.
- •MRSE within 0.50D over prior twelve months as determined by subject history.
- •7. Subjects who are soft contact lens wearers must discontinue their contact lenses for
- •at least one week prior to ACI pre-operative examination.
- •8. Subjects must have a minimum central corneal thickness of >= 500 microns in the eye
- •to be implanted.
- •9. Subjects must have a corneal power of >= 41.00D and <= 47.00D in all meridians in
- •the eye to be implanted.
- •10. Subjects must be >= 45 years and <= 60 years of age at the time of subject eligibility
- •11. Subjects must have an endothelial cell count >= 2000 cells/mm2 in the eye to be
- •12. Subjects must be willing and able to return for scheduled follow-up examinations for
- •12 months after surgery.
- •13. Subjects must demonstrate tolerance to monovision blur in the eye to be implanted
- •as determined by loose lens blur tolerance or monovision contact lens trial.
排除标准
- •1. Subjects with a difference of >1.00D between the spherical equivalent manifest
- •refraction and the spherical equivalent cycloplegic refraction.
- •2. Subjects with anterior segment pathology, including cataracts, in the eye to be
- •3. Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease, or any
- •corneal abnormality (including endothelial dystrophy, guttata, recurrent corneal
- •erosion, etc.) in the eye to be implanted.
- •4. Subjects with ophthalmoscopic or topographic signs of keratoconus (or keratoconus
- •suspect) or keratoectasia in the eye to be implanted.
- •5. Subjects with dry eye as determined by objective testing; anesthetized Schirmer*s
- •test result <10 mm or a tear break-up time (TBUT) less than 10 seconds are
- •6. Subjects taking chronic systemic medications known to exacerbate or induce
- •moderate to severe dry eye in so far as measures of TBUT and Schirmers are
- •decreased or borderline per Exclusion Criterion #5. Subjects taking the following
- •classes of medications should be evaluated: anti-depressants, anti-histamines, betablockers,
- •phenothiazines, atropine and atropine derivatives, oral contraceptives,
- •anxiolytics, diuretics, anti-cholinergics, and anti-arrhythmics.
- •7. Subjects with distorted or unclear corneal mires on topography maps of the eye to be
- •8. Subjects with macular degeneration, retinal detachment, or any other fundus
- •pathology that would prevent an acceptable visual outcome in the eye to be
- •9. Subjects who have worn RGP or PMMA contact lenses within the last 6 months.
- •10. Subjects who have undergone previous intraocular or corneal surgery, including
- •PRK, LASIK, CK, LASEK, and cataract surgery in the eye to be implanted.
- •11. Subjects with a history of herpes zoster or herpes simplex keratitis.
- •12. Subjects who have a history of steroid-responsive rise in intraocular pressure,
- •preoperative IOP > 21 mmHg, glaucoma, ocular hypertension, or are glaucoma
- •13. Subjects with an abnormal threshold visual field.
- •14. Subjects with a history of diagnosed diabetes, diagnosed autoimmune disease,
- •connective tissue disease, or clinically significant atopic syndrome.
- •15. Subjects on chronic systemic corticosteroids or other immunosuppressive therapy
- •that may affect wound healing, and any immunocompromised subjects.
- •16. Subjects who are using ophthalmic medication(s) other than artificial tears for
- •treatment of any ocular pathology including ocular allergy.
- •17. Subjects using systemic medications with significant ocular side effects.
- •18. Subjects who are pregnant, lactating, or of child-bearing potential and not practicing
- •a medically approved method of birth control.
- •19. Subjects with known sensitivity to planned study concomitant medications.
- •20. Subjects who are participating in any other ophthalmic drug or device clinical trial
- •during the time of this clinical investigation.
- •21. Subjects who require canthotomy to generate a lamellar dissection in the eye to be
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