First in Human Study to Assess the Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Stage 3 and 4 Keratoconus
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Keratoconus
- 发起方
- Recornea Srl
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Best Distance Spectacle Corrected Visual Acuity (BDSCVA)
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
This Study is a First In Human clinical investigation addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Medical Device: GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.
详细描述
The medical device under investigation is a sterile thin 8-mm diameter circular scaffold made of a nickel-titanium alloy (nitinol) that is intended as a permanent implant that is surgically inserted into the cornea in order to modify force by inducing a change in corneal shape and consequently improving vision. This study is aimed at adults with a stage 3- 4 keratoconus, a central K reading \> 47.2 D and RMS of coma aberration \> 2.5 μm, which are not recommended for Intrastromal Corneal Ring Segments (ICRS) and are recommended for keratoplasty. Therefore, this study represents a salvage route to preserve the cornea. Envisaged worst case scenario of failure of the experimental device patients would be redirected to keratoplasty. Study aims to treat 12 patients separated by a safety period of at least 14 days between each one allowing safety monitoring. For each patient, the following treatment strategy will be applied: * Unilateral KC: the affected eye meeting the eligibility criteria will be treated. * Bilateral KC, one eye meeting the eligibility criteria: the eligible eye will be treated. * Bilateral KC, both eyes meeting the eligibility criteria: the most severely compromised eye will be treated. Primary study objective is safety by identification or any local or systemic adverse events. Secondary objective will aim to evaluate efficacy that means a consequently improving of vision. Patients will be monitored at 1, 7, 21, 60, 180 and 365 days post implant surgery. Upon observance or any serious adverse event, increase in ocular pressure, device migration or discomfort, medical criteria or patient request, the patient will be offered for the device removed. The study will be early terminated if 3 patients have the experimental device removed for any reason or 4 patients withdraw from study.
研究者
入排标准
入选标准
- •Signed and dated informed consent form.
- •Male and female ≥ 18 years old.
- •Not recommended for ICRS.
- •Recommended for keratoplasty.
- •Minimum corneal thickness ≥ 350 μm.
- •Best Distance Spectacle Corrected Visual Acuity (BDSCVA) with the ETDRS test ≥ 0.30 logMAR (\<= 0,50 decimal notation).
- •BCVA with RGP contact lens with the ETDRS test 10 letters or more than BCVA with spectacles.
- •Have stable or stabilized disease for 12 months (in case of crosslinking, it must have been done at least 12 months prior to intervention).
- •Have a KC stage 3-4 according to Investigator's judgement, with a central K readings \> 47.2 D and RMS of coma aberration \> 2.5 μm.
- •Have no known or suspected allergy to nickel.
排除标准
- •Inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent.
- •Untreated progressive KC.
- •Single functioning eye.
- •Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking.
- •Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal Investigator, may be contraindicated.
- •Suspected or known intolerance or hypersensitivity to any of the treatments indicated in the CIP and/or to any component of the device (i.e. nickel).
结局指标
主要结局
Best Distance Spectacle Corrected Visual Acuity (BDSCVA)
时间窗: 6 month follow up
Changes in BDSCVA
Corrected IOP (bIOP) assessments
时间窗: 6 months follow up
Changes in bIOP
Macular central thickness assessments
时间窗: 6 months follow up
Changes in macular central thickness
Incidence of Treatment-Emergent adverse events , classification and related severity
时间窗: 6 months follow up
Assessments, classification and related severity of Serious Adverse Device Effects (SADE), Adverse Events (AE) and Serious Adverse Events (SAE) and
Slit lamp corneal assessment. Observations will be graded as follows:0- Absence 1- Mild 2- Moderate 3- Severe
时间窗: 6 months follow up
Corneal inflammation Corneal infection Corneal neovascularization Corneal stromal lysis Corneal melting Corneal stromal infiltration Corneal neo vessels Persistent corneal epithelial defects
Epithelial corneal thickness assessments
时间窗: 6 months follow up
Changes in total and epithelial corneal thickness (central and minimum)
Intraocular pressure (IOP) assessments
时间窗: 6 months follow up
Changes in IOP
Subjective numeric scale related to several ocular symptoms, graded from 0 to 10. lower scores reflect better symptomatology outcome
时间窗: 6 month follow up
Subjective numeric scale elated to pain, foreign body sensation, tearing, photophobia, glare and halos.
Corneal endothelium assessments
时间窗: 6 months follow up
Change in the number of cells/mm\^2 in the corneal endothelium
次要结局
- Measurement of topographic keratometry values(6 month follow up)
- Measurement of topographic astigmatism(6 month follow up)
- Measurement of refractive astigmatism(6 month follow up)
- Assessment of the centration of the intracorneal implant(6 month follow up)
- Best Corrected Visual Acuity(BCVA) with rigid gas permeable(RGP) contact lens (RGP-BCVA)(6 month follow up)
- Measurement of manifest refraction sphere equivalent (MRSE)(6 month follow up)
- Measurement of irregularity index (IR)(6 month follow up)
- Measurement of Uncorrected Visual Acuity (UCVA)(6 month follow up)
- Measurement of Optical surface index (OSI) related to Optical Quality(6 month follow up)
- Measurement of Root Mean Square (RMS) related to Optical Quality(6 month follow up)
- Assessment of the corneal applanation(6 month follow up)
- Measurement of biomechanical properties and characterization of the cornea by measuring Deflection Amplitude Ratio (DAR: Deflection Amplitude Ratio)(6 month follow up)
- Measurement of biomechanical properties and characterization of the cornea by measuring Stiffness Parameter-A1 (SP-A1) and Stress-Strain Index (SSI)(6 month follow up)
- Measurement of vision Related Quality of Life (VRQoL)(6 month follow up)
- Measurement of biomechanical properties and characterization of the cornea by measuring ,Integrated Radius(6 month follow up)
- Measurement of biomechanical properties and characterization of the cornea by measuring, Ambrósio Relational Thickness horizontal (ARTh)(6 month follow up)
- Measurement of biomechanical properties and characterization of the cornea by measuring Stress-Strain Index (SSI)(6 month follow up)