Comparison Between a Toric Monofocal and Multifocal Intraocular Lens
Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.
研究概览
详细说明
This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.
Inclusion criteria for research participants.
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.
The demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.
The preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).
The intraoperative data will be the power of the implant and any complications, if applicable.
The postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).
4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.
Refractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.
Changes will determine its stability in the coronal plane around the visual axis.
The intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.
The record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Visp、瑞士、3930
- Vista Alpina Eye Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Cataract (with or without presbyopia)
- No pre-existing ocular pathology or history of ocular surgery
- No phacodonesis
PEX patients (pseudoexfoliation syndrome) can be included.
Exclusion Criteria:
To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.
In particular the patients with the following pathologies will be excluded:
- Irregular astigmatism.
- Cases of uncontrolled glaucoma.
- Intraocular inflammation.
- Narrow anterior chambers (2.5 mm).
- Amblyopia with potential visual acuity less than 5/10.
- Any corneal pathology potentially affecting topography (e.g., keratoconus).
- Patients with a history of corneal surgery (especially refractive surgery).
- Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
- Patients with a history of ocular trauma.
- Pathological miosis.
- Patients with zonular laxity.
- Patients suffering from chronic uveitis.
- Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
ANKORIS
Cataract surgery performed with POD26PAYT
|
|
FINEVISION TORIC
Cataract surgery performed with POD26PAYFT
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
To observe the rotational stability of the implant
大体时间:6 Months
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Observation of rotational stability of the implant
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6 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Visual Acuity
大体时间:6 Months
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To assess the visual acuities with and without correction and the best refraction to assess the benefit of the implants
|
6 Months
|
合作者和调查者
调查人员
- 首席研究员:Kristof Vandekerckhove, MD、Vista Alpina Eye Cente, Visp, Switzerland, 3930
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Cataract surgery的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的