To improve imaging of sub-RPE structures with OCT.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation of clinical outcome parameters for structural data obtained with
conventional imaging techniques and 1050 nm OCT.
Secondary outcome
- The attribution of structural characteristics to data obtained by 1050 nm OCT
in accordance with data obtained by FAG/ICG imaging and histological data
(ganglion cell, inner plexiform, inner nuclear, outer plexiform, outer nuclear,
outer limiting membrane, inner and outer photoreceptor segment interface,
retinal pigment epithelium and choroid).
- Comparison of structural data obtained with conventional imaging techniques
and 1050 nm OCT.
- Correlation between repeated scans with 1050 nm OCT within one subject.
Background summary
In many retinal diseases, a significant loss of vision is caused either by
choroidal neovascularization, or by pigment epithelium detachment. Because both
processes occur underneath the RPE-layer, they are only partially visible by
current OCT devices. This study aims to improve imaging of the sub-RPE layer.
Study objective
To improve imaging of sub-RPE structures with OCT.
Study design
Observational cross-sectional and longitudinal cohort-study.
Study burden and risks
Replacement of dye injection dependent diagnostics for macular diseases by a
non-invasive imaging technique would be a major advantage for future patients,
because dye related adverse effects could be eliminated.
Healthy volunteers are recruited for 2 visits. No side effects are anticipated
for OCT measurements. If adverse effects of Fluorescein and ICG injections
occur, they are expected to be mild. The risk of serious adverse effects is
low. Total study time is (2X3=) 6 hours.
Patients with macular diseases do not benefit and receive no financial
compensation. No side effects are anticipated for OCT measurements. Study
related measurements always occur in combination with regular clinical visits.
Duration of study related measurements is 20 minutes per visit (in an
exceptional case maximally 60 minutes). Burden is considered to be low. Total
study time is 2-6 hours (distributed over 4-8 visits in 1 year).
Patients due for autologous RPE/choroid graft do not benefit and receive no
financial compensation. No side effects are anticipated for OCT measurements.
Study related measurements will, in part, be scheduled together with regular
clinical visits (7 visits); additionally, a number of extra study visits (4
visits) are planned. Duration of study related measurements is 4 hours, in
total.
Patients due for enucleation do not benefit and receive no financial
compensation. No side effects are anticipated for OCT measurements. Study
related measurements occur in combination with a single regular clinical visit.
Duration of study related measurements is 20-60 minutes. Burden is considered
to be low.
Postbus 70030
3000 LM Rotterdam
NL
Postbus 70030
3000 LM Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers:
- Age >= 18 years.
- Informed consent.;Patients with macular disease:
- Age >= 18 years.
- Informed consent.
- Letter reading skill (for ETDRS visual acuity determination).
- Definite macular disease, acute or chronic, of known etiology.
- Visual acuity of study eye >= 0.05 (Snellen).;Patients due for autologous RPE/choroid graft:
- Age >= 18 years.
- Informed consent.
- Letter reading skill (for ETDRS visual acuity determination).
- Exudative or atrophic ARMD.
- Visual acuity of study eye (within 1 week prior to 1st measurements) >= 0.05 (Snellen).;Patients requiring enucleation:
- Age >= 18 years.
- Informed consent (1050 nm OCT).
- No objection (histology).
Exclusion criteria
Healthy volunteers:
- Impossibility to visualize fundus due to corneal or lenticular opacities.
- Ocular disease, eg. retinal or ophthalmic disorder affecting macular area.;Patients with macular disease:
- Impossibility to visualize fundus due to corneal or lenticular opacities.
- Inability to obtain photographs to document CNV, e.g. due to allergy to fluorescein dye, ICG or lack of venous access.
- Ocular surgery scheduled within initial 12 months of treatment.
- Ocular surgery during last 3 months, except surgery for ARMD.;Patients due for autologous RPE/choroid graft:
- Impossibility to visualize fundus due to corneal or lenticular opacities.
- Inability to obtain photographs to document CNV, e.g. due to allergy to fluorescein dye, ICG or lack of venous access.
- Ocular surgery during last 3 months.;Patients requiring enucleation:
- Ocular turbidities preventing imaging.
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 | NL22480.078.08 |