To evaluate the use of the new generation OCT in detecting retinal and choroidal changes associated with pigmented tumors of the choroid; in particular, transformations of benign lesions into malignant melanomas.
ID
Source
Brief title
Condition
- Ocular neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation of conventional diagnostics and 1050 nm OCT imaging.
Secondary outcome
- Ophthalmic examination outcome: benign or malignant aspect of lesion.
- Presence of lipofuscin indicates malignancy.
- Autofluorescence outcome: hyperautofluorescence indicates malignancy .
- Ultrasonography: thickness and diameter of the lesion
Background summary
Prevalence of melanocytic choroidal lesions is about 20% in the Caucasian
population. Differentiation between small malignant melanoma and choroidal
nevus is rather difficult. Possibly, OCT can detect early stages of
transformation of choroidal nevi into malignant melanomas.
Study objective
To evaluate the use of the new generation OCT in detecting retinal and
choroidal changes associated with pigmented tumors of the choroid; in
particular, transformations of benign lesions into malignant melanomas.
Study design
Observational cross-sectional and longitudinal cohort-study.
Study burden and risks
Patients in this study do not benefit and receive no financial compensation.
There are no anticipated major side effects. Study related measurements occur
in combination with regular clinical visits and will take about 40 minutes per
visit. There will be 3 visits in 1 year. Total study time is 2 hours. Burden is
considered to be low.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years.
- Informed consent.
- Choroidal melanocytic lesion.
Exclusion criteria
- Media opacities preventing imaging.
- Use of systemic or dermatological infrared-photosensitive medication.
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 | NL26968.078.09 |