Trial Outcomes & Findings for New Visual Acuity and Crowding Tests for Better Detection of Amblyopia (NCT NCT03505606)
NCT ID: NCT03505606
Last Updated: 2024-10-21
Results Overview
Threshold visual acuity measured in LogMAR
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
Visual acuities for each participant were measured at a single time point, on a single day; day one of each participants' recruitment.
Results posted on
2024-10-21
Participant Flow
Examination of visual acuity using the Sonksen Logmar test (SLT) Examination of Stereoacuity using the Frisby Stereotest and Asteroid Stereotest.
Participant milestones
| Measure |
Control
Visual acuity tests on control participants
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
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.
|
Anisometropic Amblyopes
Visual acuity tests on anisometropic amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
26
|
|
Overall Study
COMPLETED
|
24
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
4
|
Reasons for withdrawal
| Measure |
Control
Visual acuity tests on control participants
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
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.
|
Anisometropic Amblyopes
Visual acuity tests on anisometropic amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
|---|---|---|---|
|
Overall Study
Unable to complete testing / poor co-operation
|
0
|
1
|
0
|
|
Overall Study
Under observation at Orthoptic clinic for high bilateral hypermetropia
|
1
|
0
|
0
|
|
Overall Study
Stimulus deprivation / previous haemangioma
|
0
|
1
|
0
|
|
Overall Study
Poor compliance with refractive correction
|
0
|
0
|
1
|
|
Overall Study
Insufficient anisometropia
|
0
|
0
|
2
|
|
Overall Study
Ectopia Lentis
|
0
|
0
|
1
|
|
Overall Study
alternation of amblyopic eye
|
0
|
1
|
0
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Control
n=24 Participants
Visual acuity tests on control participants
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Strabismic/Mixed Amblyopes
n=22 Participants
Visual acuity tests on strabismic/mixed amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Anisometropic Amblyopes
n=22 Participants
Visual acuity tests on anisometropic amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
7.4 years
n=5 Participants • 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.
|
7.1 years
n=7 Participants • 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.
|
6.2 years
n=5 Participants • 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.
|
6.8 years
n=4 Participants • 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.
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
9 Participants
n=7 Participants • Eight participants (1 control and 7amblyopes) 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.
|
12 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
38 Participants
n=4 Participants • Eight participants (1 control and 7amblyopes) 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.
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
13 Participants
n=7 Participants • Eight participants (1 control and 7amblyopes) 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.
|
10 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
30 Participants
n=4 Participants • Eight participants (1 control and 7amblyopes) 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.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
0 Participants
n=7 Participants • Eight participants (1 control and 7amblyopes) 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.
|
0 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
0 Participants
n=4 Participants • Eight participants (1 control and 7amblyopes) 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.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
22 Participants
n=7 Participants • Eight participants (1 control and 7amblyopes) 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.
|
20 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
66 Participants
n=4 Participants • Eight participants (1 control and 7amblyopes) 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.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
0 Participants
n=7 Participants • Eight participants (1 control and 7amblyopes) 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.
|
2 Participants
n=5 Participants • Eight participants (1 control and 7amblyopes) 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.
|
2 Participants
n=4 Participants • Eight participants (1 control and 7amblyopes) 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.
|
|
Region of Enrollment
United Kingdom
|
24 participants
n=5 Participants • 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.
|
22 participants
n=7 Participants • 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.
|
22 participants
n=5 Participants • 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.
|
68 participants
n=4 Participants • 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.
|
|
LogMAR visual acuity
Right eye (controls), amblyopic eye (amblyopes) (SLT)
|
-0.077 logMAR
STANDARD_DEVIATION 0.094 • n=5 Participants • 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.
|
0.352 logMAR
STANDARD_DEVIATION 0.231 • n=7 Participants • 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.
|
0.195 logMAR
STANDARD_DEVIATION 0.112 • n=5 Participants • 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.
|
0.193 logMAR
STANDARD_DEVIATION 0.225 • n=4 Participants • 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.
|
|
LogMAR visual acuity
Left eye (controls), Fellow eye (amblyopes) (SLT)
|
-0.079 logMAR
STANDARD_DEVIATION 0.094 • n=5 Participants • 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.
|
-0.019 logMAR
STANDARD_DEVIATION 0.083 • n=7 Participants • 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.
|
-0.032 logMAR
STANDARD_DEVIATION 0.089 • n=5 Participants • 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.
|
-0.034 logMAR
STANDARD_DEVIATION 0.088 • n=4 Participants • 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.
|
PRIMARY outcome
Timeframe: 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.
Threshold visual acuity measured in LogMAR
Outcome measures
| Measure |
Control
n=48 eyes
Visual acuity tests on control participants
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Strabismic/Mixed Amblyopes
n=44 eyes
Visual acuity tests on strabismic/mixed amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Anisometropic Amblyopes
n=44 eyes
Visual acuity tests on anisometropic amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
|---|---|---|---|
|
Visual Acuity (LogMAR)
Luminance acuity Right eye (control) or Amblyopic eye (amblyopes)
|
0.004 logMAR
Standard Error 0.024
|
0.551 logMAR
Standard Error 0.065
|
0.320 logMAR
Standard Error 0.025
|
|
Visual Acuity (LogMAR)
Luminance acuity Left eye (control) or Fellow eye (amblyopes)
|
0.005 logMAR
Standard Error 0.023
|
0.115 logMAR
Standard Error 0.028
|
0.149 logMAR
Standard Error 0.022
|
|
Visual Acuity (LogMAR)
Contrast modulated acuity - Right eye (control) or Amblyopic eye (amblyopes)
|
0.361 logMAR
Standard Error 0.023
|
0.836 logMAR
Standard Error 0.050
|
0.676 logMAR
Standard Error 0.028
|
|
Visual Acuity (LogMAR)
Contrast modulated acuity - Left eye (controls) or Fellow eye (amblyopes)
|
0.358 logMAR
Standard Error 0.021
|
0.470 logMAR
Standard Error 0.026
|
0.479 logMAR
Standard Error 0.023
|
PRIMARY outcome
Timeframe: 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.
Foveal critical crowding distance measured in degrees
Outcome measures
| Measure |
Control
n=48 eyes
Visual acuity tests on control participants
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Strabismic/Mixed Amblyopes
n=44 eyes
Visual acuity tests on strabismic/mixed amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
Anisometropic Amblyopes
n=44 eyes
Visual acuity tests on anisometropic amblyopic participants.
Visual acuity tests: Participants to have visual acuity tested with the three modified vision tests.
|
|---|---|---|---|
|
Foveal Crowding Distance (Degrees)
Foveal crowding distance repeated format - Left eye (controls) and Fellow eye (amblyopes)
|
0.103 Degrees
Standard Error 0.004
|
0.113 Degrees
Standard Error 0.007
|
0.120 Degrees
Standard Error 0.009
|
|
Foveal Crowding Distance (Degrees)
Foveal crowding distance Trigram format- Right eye (controls) and Amblyopic eye (amblyopes)
|
0.088 Degrees
Standard Error 0.008
|
0.501 Degrees
Standard Error 0.144
|
0.197 Degrees
Standard Error 0.014
|
|
Foveal Crowding Distance (Degrees)
Foveal crowding distance repeated format - Right eye (controls) and Amblyopic eye (amblyopes)
|
0.096 Degrees
Standard Error 0.011
|
0.561 Degrees
Standard Error 0.122
|
0.225 Degrees
Standard Error 0.025
|
|
Foveal Crowding Distance (Degrees)
Foveal crowding distance trigram format - Left eye (controls) and Fellow eye (amblyopes)
|
0.088 Degrees
Standard Error 0.008
|
0.106 Degrees
Standard Error 0.008
|
0.110 Degrees
Standard Error 0.009
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Strabismic/Mixed Amblyopes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anisometropic Amblyopes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mrs Louisa Haine - Lecturer in Vision Sciences
Anglia Ruskin University
Phone: 01223695445
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place