Cataracts Clinical Trial
— ASICSOfficial title:
ASICS: Aberrometry and Straylight Measurements as an Indication for Cataract Surgery
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. We also ask patients before and after cataract surgery how they themselves perceive the quality of their vision. We do this with different patient-reported outcomes. We 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, we aim to further improve patient care and prevent unnecessary surgery.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | November 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amphia | Breda | Noord-Brabant |
Lead Sponsor | Collaborator |
---|---|
Amphia Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relationship between postoperative Catquest-9SF score and preoperative Catquest-9SF score, aberrometry (expressed as log[VSX]), and straylight (expressed as log[s]) | With linear mixed modelling, investigate the relationship of postoperative Catquest-9SF score with the preoperative Catquest-9SF score, preoperative aberrometry measurements (log[VSX]), and preoperative straylight measurements (log[s]) | From enrollment to one year after cataract surgery |
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