Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05230355 |
| Other study ID # |
CTTSDLCRG |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
January 2022 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to assess the results of subliminal subthreshold transscleral diode
cyclophotocoagulation in refractory glaucoma using the standard technique of 360 degree
application and to compare the outcome with a modified technique both in terms of efficacy
and safety.
Description:
Refractory glaucoma is glaucoma that doesn't respond favorably to surgical and/or medical
treatment to lower intraocular pressure. It can include primary open angle glaucoma, primary
angle closure glaucoma, neovascular glaucoma or silicone oil-induced glaucoma.
Cyclophotocoagulation (CPC) is a form of cycloablation using laser to treat glaucoma. It
involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting
in a reduction in aqueous secretion and hence intraocular pressure. Transscleral
cyclophotocoagulation using a continuous diode laser has been a treatment option in advanced
glaucoma cases with s¬¬uboptimal IOP control, for a long time. High treatment energy used by
diode laser cyclophotocoagulation was argued to be associated with increased frequency of
serious complications such as vision loss, hypotony, and phthisis. These concerns necessitate
modulation of the parameters of laser treatment used.
Micropulse transscleral cyclophotocoagulation (MP-TSCPC), which is a variation of
conventional continuous-wave CPC, has emerged as an attractive alternative for the treatment
of many types of glaucoma. It breaks the continuous wave laser into multiple short and
repetitive pulses that allow the tissue to cool down between applications, thus reducing
thermal damage. This strategy delivers very short energy pulses followed by rest periods,
which is known as "duty cycle" and is defined as the ratio of time that a laser is delivering
energy vs resting (ON/OFF). For this procedure, an infrared diode laser is used to stimulate
the ciliary body structures and the uveoscleral pathway. This way it reduces the production
of the aqueous humour and facilitates the uveoscleral outflow, with IOP reduction as a final
effect.
Despite promising results, only few clinical studies are published on MP-TSCPC and most of
them are retrospective studies refer to patients having previous continuous wave transscleral
cyclophotocoagulation. Moreover, Several parameters and protocols have been studied in other
reports in an attempt to refine the standard technique aiming to improve the outcomes without
increasing the adverse effects.
