A Prospective, Randomized, Comparative, Post-marketing clinical study to assess and compare the clinical outcomes and patient satisfaction of two Hydrophobic EDOF Toric intraocular lenses following bilateral implantation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm).
研究概览
简要总结
Description:
EYECRYL-SERT (model no. PLHFD6T), Preloaded HydrophobicEDOFToric Lens are single piece posteriorchamber IOLs. The overall diameter of the lens is 13 mm and the optic diameter is 6 mm. These IOLs are designed to be surgically implanted in the human eye as a replacement for the natural crystalline lens. These IOLs are made from medicalimplantable grade hydrophobic material with less than 5 % water content. This IOL material have refractive index of 1.52 at 35°C. Hydrophobic NY incorporates natural yellow chromophore, which absorbs the UV light and filters violet light. It has <2% transmission at 400 nm and ≤ 10% Cut-off at 405 nm wavelength. The EYECRYL- SERT Hydrophobic Intraocular lenses have a biconvex optical shape and aspheric surface. The posterior surface of the intraocular lenses has a 360° square edge to reducethe chances of PCO.
The TECNIS Simplicityâ„¢ Delivery System Model DIU contains the TECNIS Eyhanceâ„¢ Toric II IOL, which is a one-piece, foldable, posterior chamber lens with anoverall diameter of 13.0 mm and an optic diameter of 6.0 mm. All IOL optical designsare associated with a certain amount of depth of focus. For monofocal IOLs, the amount of depth of focus is typically limited. The TECNIS Eyhanceâ„¢ Toric II IOL use an aspheric anterior surface that creates a small continuous increase in central lens powerwithin the 1 mm diameter
Purpose: To compare the visual performance of both Hydrophobic EDOF Toric Lens
To evaluate the patient satisfaction and quality of vision between the two IOLs, using a subjective questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms.
- •Best corrected visual acuity to be better than 20/30 after cataract removal and IOL implantation as estimated by potential acuity meter (PAM) or surgeon estimation
- •â‰¤ 1.0 D of preoperative keratometric astigmatism
- •Clear intraocular media other than cataract.
- •Given written informed consent by subject.
- •Subjects are willing and able to comply with schedule for follow- up visits.
- •Subjects should be 22 years or older.
排除标准
- •Systemic disease that could increase the operative risk or confound the outcome.
- •Systemic medications that may confound the outcome or increase the risk to the subject in the opinion of the investigator (tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome)).
- •Ocular condition that may predispose for future complications.
- •Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
- •Pregnant, lactating woman during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes.
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity loss to 20/30 or worse.
- •If preclinical testing or risk analysis indicates potential for substantially increased light scatter over a monofocal lens, then exclude subjects who are expected to require retinal laser treatment.
结局指标
主要结局
Binocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm).
时间窗:  Pre-operative Visit/Screening Visit |  Surgery Visit/Intra-operative Visit |  Day 1 (1 - 2 days post-operative) |  Week 1 (7 - 14 days post-operative) |  Month 1 (30 - 60 days post-operative) |  Month 6 (120 - 180 days post-operative) |  Month 12 (330 - 420 days post-operative)
次要结局
- 1) Uncorrected distance visual acuity (UCDVA) [photopic](2) Uncorrected intermediate visual acuity (UCIVA) [photopic])
研究者
Dr Naren shetty
Narayana Nethralaya Banglore