NL-OMON40527尚未招募3 期
Global Multicenter Study with the Hydrophobic Acrylic (HF) Iris-Fixated PIOL for the Correction of Myopia in Phakic Eyes - HF IF PIOL Multicenter Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- OPHTEC BV
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >18 years;
- •Axial myopia that can be fully corrected with a PIOL within the power range of -2.0 to -14.5 D (i.e.: myopia ranging from approximately -1.5 to -15.5 D, depending on keratometry values);
- •Anticipated subjective astigmatism not exceeding 1.5 D in both eyes;
- •Stable refraction (±0.5 D; ±1.0 D for refractive errors>10.0 D), as expressed by manifest refraction spherical equivalent (MRSE) for >=12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history;
- •CDVA >=0.5 in each eye;
- •UDVA <= 0.5 in each eye;
- •Difference between cycloplegic and manifest refractions < 0.75 D;
- •Current contact lens wearer has a stable refraction (± 0.5 D) on 2 consecutive examination dates at least 7 days apart, and the lenses were not worn for at least 2 weeks for rigid and toric contact lenses, or 3 days for spherical soft contact lenses prior to the first refraction;
- •Minimum ACD of 3.2 mm (from epithelium to anterior lens capsule) by biometry, resulting in a critical distance between PIOL and endothelium of 1.5 mm or more as simulated with anterior segment imaging;
- •Age specific, minimum endothelial cell density as follows (According to ISO11979-10):;18 to 25 years of age 2800 cells/mm2;
- •26 to 30 years of age 2650 cells/mm2;
- •31 to 35 years of age 2400 cells/mm2;
- •36 to 45 years of age 2200 cells/mm2;
- •> 45 years of age 2000 cells/mm2
- •Any subject who is expected to have residual postoperative cylindrical refractive error of up to 1.5 D has been given the opportunity to experience his/her best spectacle vision with anticipated spherical correction only, and is willing to proceed with the surgery;
- •Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study.
- •No secondary surgical procedure planned during the course of the study (e.g. laser treatment to correct astigmatism).
排除标准
- •Ocular condition that can predispose for future complications or interfere with the ability to evaluate the safety or effectiveness of the lens;
- •Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study;
- •Use of systemic or ocular medications that can confound the outcome of the study or increase the risk to the subject;
- •Concurrent participation or participation during the last 30 days in any other clinical trial;
- •Prior intraocular or corneal surgery;
- •Patient, when examined preoperatively, not expected to achieve a postoperative CDVA of 0.5 or better;
- •Insufficient space for the intended implant (ACD measured from epithelium <3.2mm);
- •Abnormal iris (e.g. bulging or volcano shaped iris, aniridia);
- •Abnormal cornea (e.g., keratoconus, opaque cornea, recurrent erosion syndrome, scars, or other cornea pathologies);
- •Abnormal pupil (e.g. nonreactive, fixed, photopic diameter <2.0 mm);
- •Ectopic pupil (>2 mm displacement from geometric center of cornea);
- •Pupil >7 mm under scotopic conditions;
- •Ocular hypertension (>21 mm Hg)
- •Less than the minimal endothelial cell density as listed under inclusion criteria;
- •Coefficient of variation of endothelial cell area >=0.45 (in both eyes);
- •Endothelial disease that may potentially affect the visual outcome;
- •History of retinal detachment;
- •Evidence of retinal vascular disease or history of hypercoagulability;
- •Glaucomatous changes in the retina or visual field;
- •Glaucoma or glaucoma suspect;
- •Any form of cataract;
- •Corticosteroid responder;
- •Active intraocular inflammation or recurrent ocular inflammatory condition;
- •Monocular vision;
- •Amblyopia;
- •Microphthalmos or macrophthalmos;
- •Immuno-compromised by steroids and/or antimetabolites;
- •Pregnant, lactating, or plans to become pregnant during the course of the study
- •Condition associated with fluctuation of hormones that could lead to refractive changes;
- •Diabetes mellitus;
- •Mentally retarded;
- •Aged under 18;
- •Surgical difficulty at the time of surgery which might increase the potential for complications;
- •Not able to meet the extensive postoperative evaluation requirements.
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