CataractsASICSNCT06257914
Aberrometry and Straylight Measurements as an Indication for Cataract Surgery
An observational study of Cataracts and Cataract Surgery, run by Amphia Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts, Cataract Surgery
- What is being tested?
- Catquest-9SF
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 May 2024to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ophthalmic patients with cataracts in both eyes seeking surgery on them
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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. 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.
Read the 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 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.
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 (www.oculus.de).
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 patient's 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.
- Conditions
- Cataracts, Cataract Surgery
- Being tested
- Catquest-9SF
- Keywords
- aberrometry, straylight, PROM, cataract, indication for cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catquest-9SFDiagnostic test
Also called Aberrometry (iTrace), Straylight measurement (C-Quant)
Measurement of self-assessed visual function with Catquest-9SF, measurement of ocular aberrations with iTrace (Tracey Technologies), and straylight measurements with C-Quant (Oculus)
| Study group | Role | What they receive |
|---|---|---|
| Cataract | Patients with cataract in both eyes Receives: Diagnostic Test: Catquest-9SF |
What is being measured
The primary outcome is the main question the study is designed to answer.
log(VSX)
preoperative aberrometry measurements, expressed as log(VSX)
Measured: From enrollment to one year after cataract surgery
log(s)
preoperative straylight measurements, expressed as log(s)
Measured: From enrollment to one year after cataract surgery
preoperative Catquest-9SF score (expressed as Rasch score)
preoperative Catquest-9SF score, expressed as Rasch score
Measured: From enrollment to one year after cataract surgery
postoperative Catquest-9SF score (expressed as Rasch score)
postoperative Catquest-9SF score, expressed as Rasch score
Measured: From enrollment to one year after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start6 May 2024
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amphia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nic J Reus, MD, PhD, Principal investigator, Amphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257914
- Sponsor's protocol ID
- N2024-0666
- Acronym
- ASICS
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASICS: Aberrometry and Straylight Measurements as an Indication for Cataract Surgery
- ClinicalTrials.gov ID
- NCT06257914
- Acronym / sponsor ID
- ASICS / N2024-0666
- Conditions
- Cataracts, Cataract Surgery
- Keywords
- aberrometry, straylight, PROM, cataract, indication for cataract surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amphia HospitalUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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 (www.oculus.de).
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 patient's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract | – | Diagnostic Test: Catquest-9SFPatients with cataract in both eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmic patients with cataracts in both eyes seeking surgery on them
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catquest-9SFAlso: Aberrometry (iTrace), Straylight measurement (C-Quant)Measurement of self-assessed visual function with Catquest-9SF, measurement of ocular aberrations with iTrace (Tracey Technologies), and straylight measurements with C-Quant (Oculus) | Diagnostic test | Cataract |
Primary outcome
log(VSX)
Time frame: From enrollment to one year after cataract surgery
preoperative aberrometry measurements, expressed as log(VSX)
log(s)
Time frame: From enrollment to one year after cataract surgery
preoperative straylight measurements, expressed as log(s)
preoperative Catquest-9SF score (expressed as Rasch score)
Time frame: From enrollment to one year after cataract surgery
preoperative Catquest-9SF score, expressed as Rasch score
postoperative Catquest-9SF score (expressed as Rasch score)
Time frame: From enrollment to one year after cataract surgery
postoperative Catquest-9SF score, expressed as Rasch score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nic J Reus, MD, PhD principal investigator
Amphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataracts and Cataract Surgery, run by Amphia Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
log(VSX) (time frame: From enrollment to one year after cataract surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.