A prospective multi centre real world clinical study with objective and subjective evaluation of visual performance, patients’ satisfaction after “Naturo†trifocal diffractive hydrophilic intraocular Lens implantation with phacoemulsification
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 7. Photic phenomena by dysphotopsia questionnaire
研究概览
简要总结
Diffractive trifocal IOLs have been recently introduced to solve the aforementioned problem. Diffractive trifocal IOLs have three foci and, hence, provide a wider range of spectacle independence, especially at an intermediate distance, than bifocal IOLs. Which shows promising technology for obtaining good visual outcomes and spectacle independence in patients at different distances while minimizing visual disturbances. These lenses are intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near, intermediate and far visual functions, and reduced spectacle dependence. The study follow up will be Day0, Day1, day 7, 1,3 and 6 months comprises pre-operative, operative and post operative phase. These lenses are intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near, intermediate and far visual functions, and reduced spectacle dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 21 years or older at the time of the preoperative visit
- •Visually significant cataract in one or both eyes and willingness to have them surgically removed
- •Clear intraocular media other than cataract in both eyes (vitreous, anterior chamber)
- •Corneal astigmatism less than or equal to 0.75 D in the operative eye
- •Regular corneal topography and corneal astigmatism
- •Spontaneously expressing the desire for spectacle independence after surgery and with realistic expectation
- •Willingness to provide signed written consent prior to participation in any study related procedures
- •Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
排除标准
- •PRE-OPERATIVE
- •Age of patient less than 21 years
- •Active Ocular disease in the operative eye for example chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma unresponsive to medication, corneal decompensation and corneal endothelial cell insufficiency
- •Subject with any systemic disease that could increase operative risk or pull found the outcome
- •Pregnant or lactating or planning a pregnancy at the time of enrolment
- •Significant irregular corneal astigmatism
- •Any ocular Co morbidity, amblyopia, axial length more than 25.0 mm
- •Pupil abnormality (non-reactive Tonic pupil, abnormally shaped pupil or pupil that do not dilate under mesopic or scotopic condition) patient on chloroquine treatment
- •Degenerative ocular disorder (macular degeneration, optic nerve atrophy, retinal disorder, corneal guttata, post keratoplasty, corneal scarring,aniridia, amblyopia, previous intraocular surgery (corneal glaucoma or vitreo-retinal surgery) pseudoexfoliation syndrome, intra ocular tumour
- •Any patient who is taking part in another study involving ocular surgery
- •Subject is an employee or immediate family member of Sponsor or investigator’s study staff INTRA-OPERATIVE
- •Complications occurring during cataract extraction surgery (e.g., torn anterior capsule; posterior capsular rupture, corneal injury such as significant detachment of Descemet’s membrane or significant corneal endothelial damage, inability to adequately remove the crystalline lens material,
- •Vitreous loss or prolapse
- •Zonular weakness, dehiscence or rupture
- •Any capsular bag pathology, fibrosis, or opacification that could not be visualized prior to removing the cataract
- •Any method of anterior capsulotomy other than specified in the protocol (Continuous Curvilinear Capsulorhexis)
- •Significant anterior chamber bleeding
- •Wound burn
- •Pupil diameter less than 6 mm post mydriatic injection
- •Capsulorhexis less than 5 mm and more than 6.5 mm in diameter will be excluded
- •Iris incarceration or damage, excessive iris mobility, or need for iris manipulation prior to or at the time of implantation
- •Mechanical or surgical manipulation required to enlarge pupil prior to or at the time of IOL implantation
- •Any complication that may affect the postoperative lens centration or tilt or that may require additional interventional procedures for correction
- •Lens Element damage
- •Inability to fixate the IOL in the desired position.
结局指标
主要结局
7. Photic phenomena by dysphotopsia questionnaire
时间窗: 6 months
1. Uncorrected distance visual acuity (UDVA) with ETDRS chart
时间窗: 6 months
2. Corrected distance visual acuity (CDVA) with ETDRS chart
时间窗: 6 months
3. Distance corrected intermediate visual acuity (DCIVA) with ETDRS chart
时间窗: 6 months
4. Uncorrected intermediate visual acuity (UIVA) with ETDRS chart
时间窗: 6 months
5. Distance corrected near visual acuity (DCNVA) with ETDRS chart
时间窗: 6 months
6. Contrast sensitivity
时间窗: 6 months
次要结局
- 1. Quality of Vision Index (QVI)(2. Spherical equivalent)
研究者
Dr Ashvin Agarwal
Dr. Agarwals Eye Hospital