A prospective, randomized clinical study of two phakictoric implantablelenses to outcome in in patients with moderate to high myopia and astimatism.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism.
研究概览
简要总结
Product details: Eyecryl Phakic Toric Intra Ocular Lens (IOLs) is a monofocal hydrophilic acrylic foldable single-piece posterior chamber intraocular lens designed to be surgically implanted into the posterior chamber of the eye in ciliary sulcus in front of natural crystalline lens for correction or reduction of myopia and myopia with astigmatism.
This global phase IV study will compare two phakic toric implantable lenses in patients with moderate to high myopia and astigmatism. Investigational product for the study is Eyecryl Phakic Toric (Hydrophilic Acrylic Foldable Phakic Toric IOL) manufactured by Biotech Vision Care Pvt Ltd. and comparator product is Visian Toric ICL of STAAR Surgical Company.
Objective of study is to compare the efficacy and the residual refractive error of EYECRYL Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism and following efficacy and safety parameters will be measured
Efficacy Parameters:
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Rotational Stability
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Visual Acuity
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Vault
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IOP
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Corneal Thickness
6.Subjective refraction
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Spherical equivalent
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Astigmatism
-
Endothelial cell count
-
Cell hexogonality
-
CV in cell size
-
IOL discoloration
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IOL tilt
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IOL decentration
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Ophthalmoscopy
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Slit lamp examination-Fundus visualization, Corneal status, sign of inflammation, pupillary block, status of anterior and posterior capsule, IOL opacity
Safety Parameters:
1.Cystoid macular oedema
2.Hypopyon
3.Endophthalmitis
4.Lens dislocation
5.Pupillary Block
6.Retinal Detachment
7.Secondary Surgical intervention
8.Corneal stroma oedema
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients 21 years old or older.
- •Calculated IOL Power is within the range of the investigational IOLs
- •Corneal Cylindrical error within the range defined in the clinical investigation plan
- •Subject has monocular UCVA 0.5 LogMAR or worse
- •Subject has had a stable refraction (±0.5D; ±1.0D for higher refractive errors), as expressed by manifest refraction spherical equivalent (MRSE) for a minimum 12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history.
- •Subject, who is a current contact lens wearer, needs to demonstrate a stable refraction (±0.5D) expressed as MRSE, on two consecutive examination dates and stability of the refraction is determined by the following criteria: a.
- •Contact lenses were not worn for at least 2 weeks or 3 days prior to the first refraction.
- •Two refractions were performed at least 7 days apart.
- •Subject, who is expected to have residual postoperative cylindrical refractive error of ≥1D, has been given the opportunity to experience his/her best spectacle vision with the anticipated correction.
- •Expected dilated pupil size at least large enough to visualize the axis marking.
- •Patients willing to attend all follow-up appointments
- •Patients must sign and be given a copy of the written Informed Consent form
- •Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
排除标准
- •Subject with acute and chronic disease or illness that would increase the operative risk or confound the outcomes of the evaluation.
- •Subject taking systematic medication that can confound the outcome of the study or increase the risk to the subject
- •Subject with ocular condition that may predispose the subject to future complications
- •Subject with previous intraocular or corneal surgery
- •Subject with less than the minimum endothelial cell density 2000 cells/mm² at the time of enrollment
- •Pregnant or planning to become pregnant, or is lactating during the course of the evaluation
- •Other condition associated with fluctuation of hormones
- •ACD measured from the endothelium lower than 2.8 mm
- •Concurrent participation in another drug or device evaluation.
- •Any cataract of any grade
- •Coefficient of variation of endothelial cell area >0.45
- •Monocular subject
- •Vulnerable subjects.
结局指标
主要结局
To compare the efficacy and the residual refractive error of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patient with co-existing astigmatism.
时间窗: Post-operative 1 Day | Post-operative 7 Days ± 2 Days | Post-operative 1 Month ± 7 Days | Post-operative 3 Month ± 7 Days | Post-operative 6 Month ± 14 Days | Post-operative 12 Month ± 30 Days
次要结局
- To evaluate and compare the safety of EYECRYLTM Phakic toric versus Visian® Toric ICL in moderate to high myopic patients with co-existing astigmatism(Post-operative 1 Day)