Refractory Open Angle GlaucomaNCT01908985
Ocular Fluorophotometry for Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
A study testing high intensity focused ultrasound for cyclodestruction in the eye in people with Refractory Open Angle Glaucoma, run by EyeTechCare.
Trial summary
Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Open Angle Glaucoma
- What is being tested?
- high intensity focused ultrasound for cyclodestruction in the eye
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- refractory primary open-angle glaucoma (POAG)
- IOP> 21 mm Hg and <32 mm Hg with an optimal treatment.
- Lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...)
- Lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of HIFU treatment.
- Male or female age (s) of at least 18 and able to give informed consent
- Patient who signed the informed consent form
- Patient affiliated to a social security scheme
Who cannot join
- History of glaucoma by placing a drainage implant (valves, pipes ...)
- previous refractive procedures preventing accurate measurement of intraocular pressure (PRK, LASIK)
- General treatment which may alter IOP began in the month before the HIFU procedure
- Patient monophthalmus
- thyroid orbitopathy
- History of ocular or retrobulbar tumor
Show all 12Show fewer
- Cyclodialysis
- choroidal hematoma or uprising choroidal
- Anatomy of the eyeball inadequate treatment or medical device (eye too small or too large)
- Pregnancy, breastfeeding, lack of contraceptive use among women at risk of having a child
- Participation in another clinical investigation of a medical or surgical treatment can affect the intraocular pressure in the three months preceding the HIFU
- Patient minor or major protected by law
About this study
Official title: Ocular Fluorophotometry to Assess the Aqueous Humor Production for Patients With Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound.
Population selected:
Read more
- Patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma.
The purpose of our study is:
- To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry.
Planning:
- First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase.
- Second phase: 6 patients
Read the detailed description
Main outcome criteria:
Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.
- Conditions
- Refractory Open Angle Glaucoma
- Being tested
- high intensity focused ultrasound for cyclodestruction in the eye
- Keywords
- glaucoma, high intensity focused ultrasound, aqueous humor, fluorophotometry
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity focused ultrasound for cyclodestruction in the eyeProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- EyeTechCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908985
- Sponsor's protocol ID
- EYEMUST-FLUO
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 19 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Fluorophotometry to Assess the Aqueous Humor Production for Patients With Glaucoma Treated With Cyclo-coagulation Using High Intensity Focused Ultrasound (HIFU).
- ClinicalTrials.gov ID
- NCT01908985
- Acronym / sponsor ID
- EYEMUST-FLUO
- Conditions
- Refractory Open Angle Glaucoma
- Keywords
- glaucoma, high intensity focused ultrasound, aqueous humor, fluorophotometry
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- EyeTechCareIndustry (pharma, biotech, devices)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monocentric prospective study conducted in two phases evaluating the secretion and elimination of aqueous humor by fluorophotometry in patients with glaucoma treated with cyclo-coagulation with ultrasound.
Population selected:
- Patients with refractory open angle glaucoma despite previous treatments currently validated for glaucoma.
The purpose of our study is:
- To evaluate the mechanism of action of glaucoma treatment by cyclo-coagulation with high intensity focused ultrasound in studying the secretion and elimination of aqueous humor by fluorophotometry.
Planning:
- First phase: 2 patients (feasibility study) If reduction of at least 10% of the flow of aqueous humor production at one month in the first two patients in the feasibility study, further in second phase.
- Second phase: 6 patients
Detailed description
Main outcome criteria:
Reduction of aqueous humor flow at 6 months compared with the pretreatment of aqueous humor flow.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- refractory primary open-angle glaucoma (POAG)
- IOP> 21 mm Hg and <32 mm Hg with an optimal treatment.
- Lack of history of cyclo-destruction of the ciliary body (laser diode, cold ...)
- Lack of intraocular surgery or laser therapy in the eye seen in the three months preceding the date of HIFU treatment.
- Male or female age (s) of at least 18 and able to give informed consent
Key exclusion criteria (12 listed)
- History of glaucoma by placing a drainage implant (valves, pipes ...)
- previous refractive procedures preventing accurate measurement of intraocular pressure (PRK, LASIK)
- General treatment which may alter IOP began in the month before the HIFU procedure
- Patient monophthalmus
- thyroid orbitopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high intensity focused ultrasound for cyclodestruction in the eye | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
Related trials for Refractory Open Angle Glaucoma
Recruiting
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Open Angle Glaucoma (OAG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity focused ultrasound for cyclodestruction in the eye in people with Refractory Open Angle Glaucoma, run by EyeTechCare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.