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Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)

Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01336907
Enrollment
0
Registered
2011-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2016-09-21

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

Conditions

Age Related Macular Degeneration, Choroidal Neovascularization

Keywords

CNV, AMD, Wet-treated CNV

Brief summary

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment. The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices. The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.

Interventions

None listed

Sponsors

Notal Vision Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis. * Intent to treat the study eye (SE) * Corrected VA better than 6/45 (20/150) in SE * Subject is capable and willing to sign a consent form and participate in the study * Age \> 55 years * Subject declared that he or she knows how to operate a computer mouse

Exclusion criteria

* Evidence of macular disease other than AMD or glaucoma in SE * Presence of any significant media opacity that precludes a clear view of the macular area as identified in the SE by biomicroscopy * Any ocular surgery performed within 3 months prior to study entry in the SE \* Participation in another study

Design outcomes

Primary

MeasureTime frameDescription
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.3-4 monthsthe measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026