This is a two armed Single Masked Pilot Study enrolling participants with Macular Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal treatment or a sham procedure to one eye. The participants will be followed for one year with visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to the small number of participants enrolled in this study the data will be analyzed by descriptive statistics and exploratory figures. Summary statistics will be produced for study and fellow eyes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
Medical College of Wisconsin & Froedtert Hospital
Milwaukee, Wisconsin, United States
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety and tolerability of subthreshold photothermal therapy in patients with MacTel Type 2 as assessed by CTCAE v4.0
Time frame: 3 months post treatment
Change from baseline cone density as measured by confocal adaptive optics (AOSLO)
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time frame: 1 year
Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time frame: 1 year
Development or extension post therapy of areas of deficiency in cones as measured by AOSLO
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time frame: 1 year
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