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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32046
Enrollment
265
Registered
2008-07-31
Start date
2009-06-29
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

macular diseases

Interventions

None listed

Sponsors

Oogziekenhuis Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Correlation of clinical outcome parameters for structural data obtained with conventional imaging techniques and 1050 nm OCT.

Secondary

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)