A pilot study to prove the validity of the Macubit teste, the Macuscope Test, and the measurements of the retina with the OCT, to test for early functional, and structural loss in the central part of the macula in patients at risk for developing…
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visual Acuity
Macubit test result, and testing time
Macuscope test result, and testing time
OCT measurements of the retina, RT, OS thickness, PE contour line
Classification of the macula based on stereo fundusphotography
Secondary outcome
Mutual rerlation of the test results and measurements
Background summary
AMD is the most frequent cause of visual loss in the elderly population. The
exudative type of AMD causes severe visual loss in a relatively short period of
time, in contrast the dry type of AMD causes a more gradual and less severe
loss of visual function. Nevertheless the dry type of AMD is much more frequent
than the exudative type. Recently the development of anti-VEGF therapy proved
to be a major breakthrough in the treatment of the exudative type of AMD,
unfortunately for the dry type of AMD treatment options are less promising.
Some studies showed a benefit of the intake of supplements, like anti-oxydants
especially Zinc, and omega-3 fatty acids, but to date no convincing evidence
exists regarding the efficacy of these drugs.
It is generally accepted that before visible changes can be detected in the
eye, and before functional loss can be registrated with standard examinations,
subtle changes occur in the macula leading to visual disturbances, ultimately
leading to visible lesions, like drusen, pigment epithelium changes, atrophy,
and functional loss, with small, central relative or absolute scotomas.
Perhaps treatment in this early phase can prevent ongoing damage. This
prevention would need an identification of these patients at risk. New tests
have been developed for this purpose, the Macubit en the Macuscope tests, and
these tests should be validated.
Study objective
A pilot study to prove the validity of the Macubit teste, the Macuscope Test,
and the measurements of the retina with the OCT, to test for early functional,
and structural loss in the central part of the macula in patients at risk for
developing manifest AMD, and the mutual relationship between these tests.
Study design
This is a pilot study, designed as a prospective observational study.
Patients will undergo: visual acuity test, slitlamp examination, fundus
photography, OCT, the Macubit test, and the Macuscope test.
The Macubit test the visual field in the central 4 degrees of the macula. The
Macuscope measures the amount of macular pigments, the OCT measures the
differenr layers of the retina. The fundus photography will enable a
classification of the macula of the patients.
Results of these tests will be evaluated, comparing patients with visible early
signs of AMD, with controls without visible changes.
Study burden and risks
Time involved in performing the tests is the only burden, with the exception of
the temporary discomfort caused by the mydriatics given.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Age > 45 years
Visual acuity 20/30
Clear ocular media
Willing to read the informed consent, and, following reading the information, to sign it.
Refraction between S+3 and S-5
Exclusion criteria
Diabetes Mellitus
Other eye disease, like glaucoma, uveitis, known or identifiable at screening
Design
Recruitment
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 | NL23960.018.08 |