Research with human participants

Overview of medical research in the Netherlands

WHEN MAY VARIATION IN DEVIATIONS OF STRABISMUS BE CONSIDERED AS REAL CHANGE?

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To investigate inter-examiner variability of the alternate prism and cover test (APCT) measurements of ocular deviation at near and distance fixation, and to compare variability between adults/teenagers and children.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Ocular neuromuscular disorders
Study type
Observational non invasive

ID

NL-OMON35612

Source

ToetsingOnline

Brief title

Variability of the APCT

Condition

  • Ocular neuromuscular disorders

Synonym

squinting, strabismus

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Dit onderzoek geschiedt budgetneutraal in het kader van stage orthoptie.

Intervention

Keyword :
Alternate prism and cover test, Strabismus, Variability between orthoptists

Outcome measures

Primary outcome

Inter-examiner difference in ocular deviation at near and distance fixation.

Limits of agreement at 95% level (i.e. mean difference ± 1.96*SD).

Secondary outcome

n.v.t.

Background summary

A guiding value can be helpful for clinicians to determine whether measured
differences in strabismus deviation are likely to represent a true change.

Study objective

To investigate inter-examiner variability of the alternate prism and cover test
(APCT) measurements of ocular deviation at near and distance fixation, and to
compare variability between adults/teenagers and children.

Study design

Cross-sectional prospective study.

Study burden and risks

Risks are negligible; burden is low. Study-related extra time required is 30
minutes (i.e. 3X5 minutes for actual measurements plus waiting time). Children
(< 12 yrs) will be included because variability is anticipated to be larger.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
3011 BH Rotterdam
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
3011 BH Rotterdam
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Children (2-11 years)
Elderly (65 years and older)

Inclusion criteria

Adults and teenagers (>=12).
Children (<12) allowing prism bar in front of their eyes.
Isolated strabismic horizontal deviations or combined horizontal and vertical deviations.
Patients are wearing full refractive correction.
At least one eye is able to reach and fixate in primary position.
Visual acuity of at least 20/200 in either eye with full refractive correction.
Capable of fixation movement and keeping fixation when dominant fixing eye is covered.

Exclusion criteria

Eccentric fixation
Children who did not have cycloplegic refraction in previous 6 months.

Design

Study type :
Observational non invasive
Intervention model
:
Other
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
40
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL38425.078.11