A prospective, multicenter clinical study comparing outcomes of two trifocal toric intraocular lens
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses
研究概览
简要总结
OPTIFLEX TRIO Intraocular Lenses (IOLs) are Trifocal Toric hydrophobic aspheric foldable single piece posterior chamber IOLs. These IOLs are designed to be surgically implanted into the human eye as a replacement for the natural crystalline lens. These IOLs are manufactured from medical implantable grade hydrophobic material with less than 4% water content. This material has a refractive index of 1.48 at 35°C and natural yellow chromophore which blocks the UV light and filter violet light that are harmful to retina and passes desired light essential for better contrast sensitivity. It has < 2% transmission at 400 nm and ≤ 10% Cut-off at 405 nm wavelength.
This global phase IV Clinical trial will compare two trifocal lenses in patients with cataract and coexisting astigmatism wishing to be treated for presbyopia. Investigational product is OPTIFLEX TRIO (Hydrophobic Aspheric Foldable IOL) and Comparator product is AcrySof® IQ PanOptix® (Alcon Laboratories).
Primary objective of the study is to compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses.
Following efficacy and safety parameters will be measured:
Efficacy Parameter
**1.**Visual Acuity
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Contrast Sensitivity
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Dysphotopsia
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Patient Satisfaction Questionnaire
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Manifest Refraction
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Rotational Stability
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Astigmatism
-
Spherical Equivalent
-
High Order Aberration/Internal and Total Aberration
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Defocus Curve
-
Reading Speed
-
Pupil Size under photopic as well as Mesopic condition
13. IOL Tilt
-
IOL Decentration
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IOL Discoloration
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Ophthalmoscopy
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Slit Lamp Examination
Safety Parameter: Cumulative and persistent rates of adverse events in first operative eyes in comparison to ISO 11979-7:2018 SPE historical control grid rates.
**1.**Cystoid macular oedema
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Hypopyon
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Endophthalmitis
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Lens dislocation
-
Pupillary Block
-
Retinal Detachment
-
Secondary Surgical intervention
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Corneal stroma oedema
9. 9. Raised IOP requiring treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age of patient >21 years 2.Patient diagnosed with cataract 3.Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5D as per corneal topography or keratometry 4.Calculated IOL Power is within the range of the investigational IOLs 5.Patient willing to sing informed consent form 6.Clear intraocular media other than cataract 7.Female participants of child bearing potential must be willing to ensure that they use effective contraception during the study.
排除标准
- •1.Previous intraocular or corneal surgery 2.Traumatic Cataract.
- •3.Pregnancy (as stated by patient) or lactation 4.Concurrent participation in another drug or device investigation 5.Irregular Astigmatism 6.Patient receiving chlorquine treatment 7.Subjects with any systemic disease that could increase operative risk or confound the outcome 8.Active ocular disease in the operative eye other than cataract 9.Vulnerable subjects 10.Corneal Astigmatism >4.5D.
结局指标
主要结局
To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses
时间窗: ➢ Post-operative 1 Day | ➢ Post-operative 1 Week ± 2 Days | ➢ Post-operative 1 Month ± 7 Days | ➢ Post-operative 3 Months ± 7 Days | ➢ Post-operative 6 Months ± 14 Days | ➢ Post-operative 12 Months ± 30 Days
次要结局
- To assess and compare the safety of two trifocal toric intraocular lenses(➢ Post-operative 1 Day)