NCT07164378尚未招募不适用
Prospective, MulticEnter, Randomized, International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 22
- 主要终点
- percentage of ECD loss
研究概览
简要总结
This study aims to expand the CE mark IFU of the SING IMT™ to pseudophakic (patients with an intraocular lents) patients with late stage of AMD (Age-Related Macular Degeneration) and bilateral central vision impairment. This randomized, international, multicenter study will evaluate the safety and efficacy of the device in this patient group. Findings will support regulatory submissions, clinical decision-making, and potential label expansion.
详细描述
Eligible AMD patients with existing IOL on both eyes will be randomized to either have the SING-IMT device placed on top of the existing IOL, or to replace the existing IOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 55 years of age or older;
- •Subjects with late-stage AMD; Have retinal findings of geographic atrophy or disciform scar with foveal involvement in both eyes;
- •Had cataract surgery (with IOL implantation in both eyes) at least 6 months prior to enrollment;
- •BCDVA no better than 20/80 and no worse than 20/800 in both eyes.
- •Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
- •Achieve using the ETS, at least 2-lines (10 or more letters) improvement in distance on the ETDRS chart in the eye scheduled for surgery.
- •Have an Anterior chambre depth (ACD) of at least 2.5 mm, measured from endothelium, in both eyes.
- •Have an ECD of at least 1600 cells per square mm in both eyes.
- •Be willing to participate in a postoperative training program for the use of the SING IMT™ implant.
- •Review and sign the IEC approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed.
- •Patient is registered with the national social security or equivalent in the country where consent is signed
- •A woman is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •13, Not a woman of childbearing potential (WOCBP): A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through to the end of the study
排除标准
- •A. Bilateral Ocular Conditions (affecting both eyes):
- •Evidence of active choroidal neovascularization (CNV), or treatment for CNV within the past six (6) months.
- •Diabetic retinopathy.
- •Retinal vascular diseases.
- •History of retinal detachment.
- •Retinitis pigmentosa.
- •Intraocular tumor.
- •Corneal Stromal or Endothelial Dystrophies (for example corneal guttata)Corneal guttata.
- •Patient predisposing to eye rubbing
- •B. Surgical Eye Conditions:
- •Narrow angle (i.e., < Schaffer grade 2).
- •Axial length <21 mm or >26 mm.
- •Any history or current ocular or intraocular inflammation, infection, or edema, including but not limited to: - Uveitis, iritis, keratitis, keratouveitis, microbial keratoconjunctivitis.
- •Plate haptic shape IOL implanted.
- •Vitrectomized eye.
- •Zonular weakness, instability, presence of pseudoexfoliation.
- •Iris abnormalities, including but not limited to: Transillumination defects (e.g., pigment dispersion syndrome), aniridia, iris neovascularization.
- •Any IOL already implanted in the sulcus.
- •Presence of toric or multifocal IOL types.
- •Optic Nerve Disease
- •C. Systemic or Other General Conditions:
- •A history of steroid-induced IOP elevation uncontrolled, glaucoma, or preoperative IOP >22 mmHg.
- •Known sensitivity to post-operative medications.
- •Significant communication impairment or severe neurological disorders.
- •Administration of any investigational product within 30 days prior to enrolment or planned participation in another clinical investigation during this study.
- •Any condition or situation that, in the opinion of the investigator, may:
- •Put the subject at significant risk,
- •Confound the clinical investigation results, or
- •Interfere significantly with the subject's participation in the study.
- •Individuals under legal care (e.g., incarcerated patients or those under legal guardianship) who are unable to understand and provide informed consent.
研究组 & 干预措施
Lens Exchange group
Experimental
SING IMT™ implantation in the sulcus after removal of the previously implanted IOL
干预措施: Lens-Exchange (Procedure)
Add-On
Experimental
SING IMT™ implantation in the sulcus in front of an existing IOL
干预措施: Add-on (Procedure)
结局指标
主要结局
percentage of ECD loss
时间窗: at baseline, then at 1, 3 and 6 months
assessed within each treatment group relative to baseline (pre-surgery). The ECD loss should not exceed 23%
percentage of ECD loss
时间窗: at baseline, then at 1, 3 and 6 months
assessed within each treatment group relative to baseline (pre-surgery). The ECD loss should not exceed 23%
次要结局
- Incision size required for device implantation(baseline)
- Number of Surgical Complications, AEs and SAEs(at baseline, then at 1, 3 and 6 months)
- Acuity(at baseline, then at 1, 3 and 6 months)
- Patient-reported outcomes(at baseline, then at 1, 3 and 6 months)
- Number of Surgical Complications, AEs and SAEs(at baseline, then at 1, 3 and 6 months)
- Acuity(at baseline, then at 1, 3 and 6 months)
- Incision size required for device implantation(baseline)
- Patient-reported outcomes(at baseline, then at 1, 3 and 6 months)
研究者
研究点 (22)
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