Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257914
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-02-06
Brief Title:
Aberrometry and Straylight Measurements as an Indication for Cataract Surgery
Sponsor:
Amphia Hospital
Organization:
Amphia Hospital
Study Overview
Official Title:
ASICS Aberrometry and Straylight Measurements as an Indication for Cataract Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASICS
Brief Summary:
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 ophthalmologists assessment of the extent to which the clouding of the lens explains the patients 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
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
Detailed Description:
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 ophthalmologists assessment of the extent to which the cloudiness of the lens explains the patients 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 ie 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
A more objective and perhaps better indicator is based on the optical quality of the eye Indeed in essence cataracts reduce the visual performance of the eye by deteriorating the optical quality of the lens The optical quality of the eye is determined by optical aberrations and light scattering Optical aberrations are deviations in the path that light rays travel that cause the light rays not to focus on a single point These aberrations can be measured with an aberrometer Light scattering is caused by small local irregularities in the refractive index in the ocular media The visual effect of light scattering in the eye is straylight This creates a veil of light over the retina which reduces the contrast of the image projected on the retina It also leads to glare from light This can be measured with the C-Quant scattered light meter wwwoculusde
Aberrations and straylight complement each other The optical quality of the eye is often expressed as the point spread function PSF in English Point Spread Function This function represents how a point light source is spread when it passes through the eye onto the retina The central part of the PSF relates to optical aberrations the peripheral part to light scattering Vision is determined by the centre of the PSF
Aberrometry and straylight measurements have been used independently to evaluate cataracts Indeed in cataracts both the amount of aberrations and straylight increase And both improve with cataract surgery However they have never been used together to predict the outcome of surgery The closest is a study in which visual acuity and stray light were used as indicators of cataract surgery In this study the investigators showed that visual acuity and straylight contributed similarly to the predictive outcome after surgery However the measurement of vision is subjective and variable Moreover a patients visual acuity is influenced by corneal aberrations internal aberrations due to cataracts as well as retinal and neural factors
With an aberrometer one can specifically measure the aberrations of the clouded lens in the eye This allows one to assess the effect of the cataract on visual acuity Therefore the investigators think the objective measurement of aberrations better reflects the optical distortions of cataract in the lens than visual acuity
And although the indication for surgery is thus not optimal the demand for excellent visual function is increasing among patients In addition the results and safety of this procedure have also continued to improve over the years This may lower the indication for cataract surgery However both for the patient and in the context of value-driven care it is important that a correct indication is made This calls for a more objective indicator for cataract surgery
The main aim of this project is to investigate whether an objective measurement of the optical quality of the eye can predict who is going to be satisfied with cataract surgery The investigators do this by investigating the correlation of the objective measurement of the optical quality of the eye with the subjective change in visual functioning
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 ie 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
A more objective and perhaps better indicator is based on the optical quality of the eye Indeed in essence cataracts reduce the visual performance of the eye by deteriorating the optical quality of the lens The optical quality of the eye is determined by optical aberrations and light scattering Optical aberrations are deviations in the path that light rays travel that cause the light rays not to focus on a single point These aberrations can be measured with an aberrometer Light scattering is caused by small local irregularities in the refractive index in the ocular media The visual effect of light scattering in the eye is straylight This creates a veil of light over the retina which reduces the contrast of the image projected on the retina It also leads to glare from light This can be measured with the C-Quant scattered light meter wwwoculusde
Aberrations and straylight complement each other The optical quality of the eye is often expressed as the point spread function PSF in English Point Spread Function This function represents how a point light source is spread when it passes through the eye onto the retina The central part of the PSF relates to optical aberrations the peripheral part to light scattering Vision is determined by the centre of the PSF
Aberrometry and straylight measurements have been used independently to evaluate cataracts Indeed in cataracts both the amount of aberrations and straylight increase And both improve with cataract surgery However they have never been used together to predict the outcome of surgery The closest is a study in which visual acuity and stray light were used as indicators of cataract surgery In this study the investigators showed that visual acuity and straylight contributed similarly to the predictive outcome after surgery However the measurement of vision is subjective and variable Moreover a patients visual acuity is influenced by corneal aberrations internal aberrations due to cataracts as well as retinal and neural factors
With an aberrometer one can specifically measure the aberrations of the clouded lens in the eye This allows one to assess the effect of the cataract on visual acuity Therefore the investigators think the objective measurement of aberrations better reflects the optical distortions of cataract in the lens than visual acuity
And although the indication for surgery is thus not optimal the demand for excellent visual function is increasing among patients In addition the results and safety of this procedure have also continued to improve over the years This may lower the indication for cataract surgery However both for the patient and in the context of value-driven care it is important that a correct indication is made This calls for a more objective indicator for cataract surgery
The main aim of this project is to investigate whether an objective measurement of the optical quality of the eye can predict who is going to be satisfied with cataract surgery The investigators do this by investigating the correlation of the objective measurement of the optical quality of the eye with the subjective change in visual functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None