High resolution 1050 nm wavelength centered spectral domain 3D Optical Coherence Tomography in Macular diseases.

Completed

• Conditions: macular diseases; 10047060

• Registration Number: NL-OMON32046
• Lead Sponsor: Oogziekenhuis Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 265

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Correlation of clinical outcome parameters for structural data obtained with<br /><br>conventional imaging techniques and 1050 nm OCT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The attribution of structural characteristics to data obtained by 1050 nm OCT<br /><br>in accordance with data obtained by FAG/ICG imaging and histological data<br /><br>(ganglion cell, inner plexiform, inner nuclear, outer plexiform, outer nuclear,<br /><br>outer limiting membrane, inner and outer photoreceptor segment interface,<br /><br>retinal pigment epithelium and choroid).<br /><br>- Comparison of structural data obtained with conventional imaging techniques<br /><br>and 1050 nm OCT.<br /><br>- Correlation between repeated scans with 1050 nm OCT within one subject. </p><br>