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New Visual Acuity and Crowding Tests for Better Detection of Amblyopia

Examination of New Visual Acuity and Clinical Crowding Tests for Better Detection of Amblyopia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03505606
Enrollment
76
Registered
2018-04-23
Start date
2019-01-01
Completion date
2021-07-01
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Keywords

Amblyopia, Visual Acuity, Crowding

Brief summary

Amblyopia, or 'lazy eye', is the reduction in vision usually in one eye, due to abnormal visual development without organic cause. It is a preventable and leading cause of monocular vision loss (prevalence of around 3%) and increases lifetime risk of bilateral visual impairment from 10% in the general population, to 18% in amblyopes. In the UK, vision screening in children aims to detect amblyopia and other undiagnosed visual conditions. Laboratory research suggest that amblyopia could be better detected by modifying standard clinical vision tests to enhance and quantify crowding. Crowding is the negative effect that surrounding features have on the visibility of a target. Crowding distance and crowding magnitude are considerably greater in amblyopic eyes than in normal healthy eyes. Modifications that should lead to improved amblyopia detection are 1) place letters closer together on a vision chart, 2) define letters by contrast, rather than luminance, and 3) use a new thinner font in the form of numbers, to allow crowding distance in central vision to be measured. In this project, these modifications will be tested in amblyopic children for the first time. Amblyopic children aged 3 to 11 years (n=32) will be recruited from ACPOS (Addenbrooke's Community Paediatric Ophthalmology Service) at ARU. They will have their vision measured with the three modified tests as well as an uncrowded test. The child will view letters and numbers on a computer screen and respond (verbally or by indicating their choice on a matching card). Testing is fun and game-like with breaks for rewards. Results will be compared to standard vision measurement (SLT: Sonksen LogMAR Test) from the child's ACPOS visit. Amblyopic data will be compared to control data from normal healthy children aged 3 to 11 years (n=200), and age-matched children with normal vision (n=16) from ACPOS (false referrals from school screening).

Detailed description

In the UK, a national vision screening is employed to detect amblyopia and other undiagnosed visual conditions in school-aged children, so that they can be managed effectively. Better detection of amblyopia could be achieved by modifying current visual acuity tests, which measure the spatial resolution limit (or capacity for clarity and sharpness) of vision and by measuring crowding distance; previously unmeasured in a clinical setting. By strengthening crowding magnitude, and better quantifying its spatial distance in paediatric populations, it is hoped that the ability to detect amblyopia, and monitor its improvement with treatment will be significantly enhanced. Three recent suggestions regarding modifications to current visual acuity tests may lead to improved detection of crowding-sensitive conditions, such as amblyopia. First, closer placement of surrounding letters to the target letter should increase the magnitude of crowding in the amblyopic eye in particular, leading to increased visual acuity differences between eyes. Second, contrast modulated stimuli should enhance crowding in amblyopic eyes. Third, a new thinner font will allow clinical measures of foveal crowding distance. In this project, these three modifications will be tested for the first time in the target clinical population. Several studies reported that optotypes (letters or symbols) on a vision chart should be placed closer together than they currently are on commercially-available charts, which use 2.5 to 5 stroke-widths separation between target and neighbouring letters. Closer placement disrupts target optotype identification in normal peripheral vision and in central vision of amblyopic eyes due to crowding. In one vision test in the proposed study, a laterally-reversible target letter (e.g., H, O, T or V) will be surrounded by four other letters (U, A, L, C). This arrangement, in which letters were separated by 0.5 optotype widths (or 2.5 stroke widths) was first formally used in the Cambridge Crowding Test. In the proposed experiments, the surrounding letters will be placed 1 stroke-width away from the target letter, the optimal position recommended by recent studies. Visual acuities for target letters will be measured for both amblyopic and non-amblyopic eyes of child participants, in a clinical environment. These results will be compared with visual acuities acquired during the clinical appointment using the Sonksen logMAR Test (SLT), which is the standard visual acuity test used in Cambridge University Hospital, Addenbrooke's Orthoptic Department In the Sonksen logMAR Test (SLT), a single line of 4 letters separated from each other by 5 stroke-widths (or 1 optotype width), is contained within a box, separated from the letters also by 5 stroke-widths. Recognition of target optotypes created by contrast-differences (second-order stimuli) is prone to greater crowding effects than is recognition of optotypes created by luminance-differences (first-order stimuli). This effect is present in normal vision, however even greater visual losses for contrast-defined targets, as well as stronger crowding effects, have been reported in amblyopia. By presenting a contrast-modulated (CM) target letter (H, O, T or V) surrounded by four other letters (U, A, L, C) placed 1 stroke-width away (in the modified Cambridge Crowding Test arrangement), this research aims to examine whether this second-order vision test will exaggerate differences between the eyes of amblyopic children, when compared to those measured in visually 'normal' children. The results will again be compared to those obtained with the Sonksen logMAR test (SLT), a first-order vision test, to compare their sensitivities to amblyopia detection. Finally, crowding distance, the spatial distance over which crowding occurs, in normal foveal (central) vision is small (2-4 arcmin) and cannot be measured with current standard clinical optotypes due to their large size (5 arcmin for 0.0 logMAR acuity). To get around this difficulty, a new vision test was recently created to quantify the crowding distance or critical spacing of crowding . It uses a new Pelli font, which is much thinner horizontally than standard clinical fonts, allowing the optotypes to get closer to each other in physical space. This 'Crowding Distance Test' permits quantification of the critical spacing of crowding for the first time in a clinical population. The new Pelli font, each optotype appearing like tall skinny numbers, has already been trialled on 'visually normal' school-aged children, but not yet examined on children with greater sensitivity to visual crowding, i.e., amblyopes. The third vision test in the proposed research, will investigate whether or not crowding distance measures made in each eye, results in greater inter-ocular differences, leading to better detection of anisometropic and strabismic amblyopia than does the current clinical standard visual acuity test, the Sonksen logMAR test (SLT). By using closer first-order target optotypes, second-order target optotypes, and quantifying crowding distance in paediatric populations, the ability to detect amblyopia and monitor amblyopia treatment, could be significantly improved for the first time since the 1960s. At that time crowding was first quantified in a clinical population of adult amblyopes and was subsequently incorporated into commercially available tests as best practice.

Interventions

DIAGNOSTIC_TESTVisual acuity tests

Participants to have visual acuity tested with the three modified vision tests.

Sponsors

Anglia Ruskin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* Test participants; Male and female 3 to 11-year-old children diagnosed by ACPOS clinicians as likely having amblyopia (strabismic or anisometropic). They will be tested following 6 weeks (or more) of refractive adaption. * Control Participants; Male and female 3 to 11-year-old children who have been falsely referred into the Hospital Eye Service (ACPOS) by the visual screening service, but have satisfactory visual functions, as per the national screening guidelines. * All participants must be able to complete the Sonsken logMAR Test (SLT) either verbally or via use of a matching card.

Exclusion criteria

* Uncorrected refractive error. * The presence of any other vision limiting medical condition, not listed in the inclusion criteria. * Any prior or existing medical history of epilepsy or seizures.

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity (LogMAR)Visual acuities for each participant were measured at a single time point, on a single day; day one of each participants' recruitment.Threshold visual acuity measured in LogMAR
Foveal Crowding Distance (Degrees)Crowding distances for each participant were measured at a single time point, on a single day; day one of each participants' recruitment.Foveal critical crowding distance measured in degrees

Countries

United Kingdom

Participant flow

Pre-assignment details

Examination of visual acuity using the Sonksen Logmar test (SLT) Examination of Stereoacuity using the Frisby Stereotest and Asteroid Stereotest.

Participants by arm

ArmCount
Control
Visual acuity tests on control participants Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
24
Strabismic/Mixed Amblyopes
Visual acuity tests on strabismic/mixed amblyopic participants. Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
22
Anisometropic Amblyopes
Visual acuity tests on anisometropic amblyopic participants. Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
22
Total68

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall Studyalternation of amblyopic eye010
Overall StudyEctopia Lentis001
Overall StudyInsufficient anisometropia002
Overall StudyPoor compliance with refractive correction001
Overall StudyStimulus deprivation / previous haemangioma010
Overall StudyUnable to complete testing / poor co-operation010
Overall StudyUnder observation at Orthoptic clinic for high bilateral hypermetropia100

Baseline characteristics

CharacteristicControlStrabismic/Mixed AmblyopesAnisometropic AmblyopesTotal
Age, Categorical
<=18 years
24 Participants22 Participants22 Participants68 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous7.4 years7.1 years6.2 years6.8 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants22 Participants20 Participants66 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants2 Participants2 Participants
LogMAR visual acuity
Left eye (controls), Fellow eye (amblyopes) (SLT)
-0.079 logMAR
STANDARD_DEVIATION 0.094
-0.019 logMAR
STANDARD_DEVIATION 0.083
-0.032 logMAR
STANDARD_DEVIATION 0.089
-0.034 logMAR
STANDARD_DEVIATION 0.088
LogMAR visual acuity
Right eye (controls), amblyopic eye (amblyopes) (SLT)
-0.077 logMAR
STANDARD_DEVIATION 0.094
0.352 logMAR
STANDARD_DEVIATION 0.231
0.195 logMAR
STANDARD_DEVIATION 0.112
0.193 logMAR
STANDARD_DEVIATION 0.225
Region of Enrollment
United Kingdom
24 participants22 participants22 participants68 participants
Sex: Female, Male
Female
17 Participants9 Participants12 Participants38 Participants
Sex: Female, Male
Male
7 Participants13 Participants10 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 250 / 26
other
Total, other adverse events
0 / 250 / 250 / 26
serious
Total, serious adverse events
0 / 250 / 250 / 26

Outcome results

Primary

Foveal Crowding Distance (Degrees)

Foveal critical crowding distance measured in degrees

Time frame: Crowding distances for each participant were measured at a single time point, on a single day; day one of each participants' recruitment.

Population: Eight participants (1 control and 7 amblyopes) were excluded. The excluded control had high bilateral hypermetropia and had previously been under the observation of an orthoptic department for possible bilateral amblyopia. Seven amblyopes were excluded due to poor compliance with their refractive correction, insufficient anisometropia, Ectopia Lentis, Haemangioma, alternation of amblyopic eye and non-compliance with testing.

ArmMeasureGroupValue (MEAN)Dispersion
ControlFoveal Crowding Distance (Degrees)Foveal crowding distance Trigram format- Right eye (controls) and Amblyopic eye (amblyopes)0.088 DegreesStandard Error 0.008
ControlFoveal Crowding Distance (Degrees)Foveal crowding distance repeated format - Right eye (controls) and Amblyopic eye (amblyopes)0.096 DegreesStandard Error 0.011
ControlFoveal Crowding Distance (Degrees)Foveal crowding distance trigram format - Left eye (controls) and Fellow eye (amblyopes)0.088 DegreesStandard Error 0.008
ControlFoveal Crowding Distance (Degrees)Foveal crowding distance repeated format - Left eye (controls) and Fellow eye (amblyopes)0.103 DegreesStandard Error 0.004
Strabismic/Mixed AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance repeated format - Left eye (controls) and Fellow eye (amblyopes)0.113 DegreesStandard Error 0.007
Strabismic/Mixed AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance Trigram format- Right eye (controls) and Amblyopic eye (amblyopes)0.501 DegreesStandard Error 0.144
Strabismic/Mixed AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance trigram format - Left eye (controls) and Fellow eye (amblyopes)0.106 DegreesStandard Error 0.008
Strabismic/Mixed AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance repeated format - Right eye (controls) and Amblyopic eye (amblyopes)0.561 DegreesStandard Error 0.122
Anisometropic AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance repeated format - Left eye (controls) and Fellow eye (amblyopes)0.120 DegreesStandard Error 0.009
Anisometropic AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance repeated format - Right eye (controls) and Amblyopic eye (amblyopes)0.225 DegreesStandard Error 0.025
Anisometropic AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance trigram format - Left eye (controls) and Fellow eye (amblyopes)0.110 DegreesStandard Error 0.009
Anisometropic AmblyopesFoveal Crowding Distance (Degrees)Foveal crowding distance Trigram format- Right eye (controls) and Amblyopic eye (amblyopes)0.197 DegreesStandard Error 0.014
Primary

Visual Acuity (LogMAR)

Threshold visual acuity measured in LogMAR

Time frame: Visual acuities for each participant were measured at a single time point, on a single day; day one of each participants' recruitment.

Population: Eight participants (1 control and 7 amblyopes) were excluded. The excluded control had high bilateral hypermetropia and had previously been under the observation of an orthoptic department for possible bilateral amblyopia. Seven amblyopes were excluded due to poor compliance with their refractive correction, insufficient anisometropia, Ectopia Lentis, Haemangioma, alternation of amblyopic eye and non-compliance with testing.

ArmMeasureGroupValue (MEAN)Dispersion
ControlVisual Acuity (LogMAR)Luminance acuity Right eye (control) or Amblyopic eye (amblyopes)0.004 logMARStandard Error 0.024
ControlVisual Acuity (LogMAR)Luminance acuity Left eye (control) or Fellow eye (amblyopes)0.005 logMARStandard Error 0.023
ControlVisual Acuity (LogMAR)Contrast modulated acuity - Right eye (control) or Amblyopic eye (amblyopes)0.361 logMARStandard Error 0.023
ControlVisual Acuity (LogMAR)Contrast modulated acuity - Left eye (controls) or Fellow eye (amblyopes)0.358 logMARStandard Error 0.021
Strabismic/Mixed AmblyopesVisual Acuity (LogMAR)Contrast modulated acuity - Left eye (controls) or Fellow eye (amblyopes)0.470 logMARStandard Error 0.026
Strabismic/Mixed AmblyopesVisual Acuity (LogMAR)Luminance acuity Right eye (control) or Amblyopic eye (amblyopes)0.551 logMARStandard Error 0.065
Strabismic/Mixed AmblyopesVisual Acuity (LogMAR)Contrast modulated acuity - Right eye (control) or Amblyopic eye (amblyopes)0.836 logMARStandard Error 0.05
Strabismic/Mixed AmblyopesVisual Acuity (LogMAR)Luminance acuity Left eye (control) or Fellow eye (amblyopes)0.115 logMARStandard Error 0.028
Anisometropic AmblyopesVisual Acuity (LogMAR)Contrast modulated acuity - Left eye (controls) or Fellow eye (amblyopes)0.479 logMARStandard Error 0.023
Anisometropic AmblyopesVisual Acuity (LogMAR)Luminance acuity Left eye (control) or Fellow eye (amblyopes)0.149 logMARStandard Error 0.022
Anisometropic AmblyopesVisual Acuity (LogMAR)Contrast modulated acuity - Right eye (control) or Amblyopic eye (amblyopes)0.676 logMARStandard Error 0.028
Anisometropic AmblyopesVisual Acuity (LogMAR)Luminance acuity Right eye (control) or Amblyopic eye (amblyopes)0.320 logMARStandard Error 0.025

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026