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临床试验/NCT06257914
NCT06257914Enrolling By Invitation不适用

ASICS: Aberrometry and Straylight Measurements as an Indication for Cataract Surgery

Amphia Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
log(VSX)

研究概览

简要总结

Cataracts are a clouding of the lens of the eye. Cataract surgery replaces the cloudy lens with a clear artificial lens. It is one of the leading causes of low vision worldwide. Since cataracts are mostly age-related, the number of patients with cataracts is increasing sharply due to an ageing population. The indication for cataract surgery is currently based on the visual impairment experienced by the patient, a measurement of visual acuity and the ophthalmologist's assessment of the extent to which the clouding of the lens explains the patient's symptoms.

It has been said that after cataract surgery, "the world opens up to you". However, about 10% of patients actually experience worse vision after surgery. This amounts to almost a whole month of potentially unnecessary surgery. It is therefore important to develop a more objective indicator for cataract surgery.

Our study focuses on measuring the optical quality of the eye before and after cataract surgery. The investigators also ask patients before and after cataract surgery how patients themselves perceive the quality of their vision. The investigators do this with different patient-reported outcomes. The investigators investigate whether the objective measurement of the optical quality of the eye can predict which patients will be satisfied with the cataract surgery. With this, the investigators aim to further improve patient care and prevent unnecessary surgery.

详细描述

Cataracts are a clouding of the lens of the eye. The symptoms of cataracts depend on where the clouding is in the lens and how extensive it is. Symptoms that patients may experience are blurred vision, poor vision at night, double vision in one eye, glare from backlight (such as from car headlights or a low sun), dulling of colours and a rapid change in refractive error. It is the most common cause of low vision in the world. Treatment for cataracts is surgical replacement of the cloudy lens for a clear artificial lens. The indication for cataract surgery is currently based on the visual impairment experienced by the patient, a measurement of visual acuity and the ophthalmologist's assessment of the extent to which the cloudiness of the lens explains the patient's symptoms.

Despite considering all these factors, it can be difficult for ophthalmologists to determine in advance which patient will benefit from cataract surgery. For example, visual acuity before surgery has been shown to be a poor indicator of cataract surgery outcome. There is also a limited relationship between the severity of clouding in the lens and the outcome of surgery. Questionnaires that assess patient-reported quality of vision (Patient Reported Outcome Measures, PROMs), such as the Catquest-9SF, also have limited predictability with regard to cataract surgery outcome. For example, the quality of vision of a significant number of patients who reported normal visual functioning before cataract surgery improves with surgery anyway.

In contrast, about 10% of all patients report that their visual functioning actually deteriorates with cataract surgery. There is also a limited correlation between how patients rate their change in visual functioning due to surgery in general (i.e., as much better, slightly better, no difference, slightly worse and much worse) and how patients report their visual functioning according to the Catquest-9SF. In other words, patients who report that their visual functioning after surgery felt much better than before sometimes report a worsening of their functioning with the Catquest-9SF questionnaire. It should be noted that the Catquest-9SF PROM is considered both clinically and scientifically the best questionnaire to measure change in visual functioning due to cataract surgery.

There are several reasons why patients may be dissatisfied after cataract surgery. In general, the more severe the discomfort caused by cataracts before surgery, the more satisfied patients are with the result obtained from the surgery. However, even a high percentage of patients with relatively few symptoms before surgery report having gained from the surgery after surgery. On the other hand, there is also a significant percentage of patients who deteriorate in visual function despite many complaints before surgery. The most commonly reported causes of dissatisfaction after cataract surgery with implantation of a standard artificial lens are dry eye and floaters. No research has been done on the extent to which these issues can be identified in advance.

Making the right indication for cataract surgery is important because surgery is irreversible. If the patient is dissatisfied with the result obtained, the old situation cannot be restored. Although the percentage of patients who are not satisfied after cataract surgery is small (10%), it is substantial in absolute numbers. The number of patients that is dissatisfied with the outcome of their cataract surgery corresponds to almost an entire month of cataract operations that, in retrospect, might better not have been performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years old,
  • Diagnosis of cataract in both eyes,
  • Based on informed consent, will undergo cataract surgery in both eyes (not necessarily immediately bilateral),
  • Expected best-corrected visual acuity ≥ 0.7 in both eyes,
  • Pupil diameter in mydriasis ≥4 mm and
  • Implantation of a (standard) monofocal, toric monofocal or (non)toric Extended Depth of Focus artificial lens.

排除标准

  • Insufficient understanding of the Dutch language to comply with study procedures,
  • Spherical refraction of ≤-15 dioptres (due to impossibility of measurement with aberrometer),
  • Corneal astigmatism of ≥3 dioptres (because of possible effect on reliability of straylight measurement),
  • Implantation of a multifocal artificial lens (because the aberrometer [still] cannot properly determine the optical quality of this type of artificial lens),
  • Cataract surgery of the second eye not performed 3 months after surgery of the first eye,
  • Comorbidity (other than cataract) that may significantly affect vision or give prolonged duration of vision recovery, such as Fuchs' endothelial cell dystrophy, significant macular degeneration, glaucoma, diabetic maculo- or retinopathy, or an experienced cerebral vascular accident,
  • A history of eye surgery (such as corneal refractive surgery and phakic lens implantation),
  • An increased risk of complicated cataract surgery, such as lens (sub)luxation, brunescent cataract, posterior polar cataract and a history of trauma to the eye,
  • Unable to be reliably measured with aberrometer or straylight meter, and
  • A peroperative or postoperative complication that significantly affects vision and has not recovered within 3 months of surgery.

结局指标

主要结局

log(VSX)

时间窗: From enrollment to one year after cataract surgery

preoperative aberrometry measurements, expressed as log(VSX)

log(s)

时间窗: From enrollment to one year after cataract surgery

preoperative straylight measurements, expressed as log(s)

preoperative Catquest-9SF score (expressed as Rasch score)

时间窗: From enrollment to one year after cataract surgery

preoperative Catquest-9SF score, expressed as Rasch score

postoperative Catquest-9SF score (expressed as Rasch score)

时间窗: From enrollment to one year after cataract surgery

postoperative Catquest-9SF score, expressed as Rasch score

次要结局

未报告次要终点

研究者

发起方
Amphia Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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