User Manual MUT_RD_009H_GB Page
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This medical device (EyeOP1 control unit and associated EYEOP-PACK consumables) is intended to treat
glaucoma. This device allows for non-invasive treatment of glaucoma via coagulation of part of the ciliary
body by using focused ultrasound in order to reduce the production of aqueous humor and thereby to
de
crease the intraocular pressure (IOP). This treatment is called a UCP Procedure (“Ultrasound Cyclo Plasty”).
This type of treatment is indicated for adult patients (over the age of 18) who have glaucoma characterized
by ocular hypertension greater than or equal to 21 mmHg (for 6-sectors protocol) and greater than or equal
to 30 mmHg (for 8-sectors protocol).
Expected clinical benefits:
-
Reduced production of aqueous humor leading to decreased intraocular pressure.
-
Non-invasive procedure enabling to perform the treatment, in one step, without opening the eyeball,
thereby reducing the risk of infection or bleeding complications.
2.2
Contra-indications
Contra-indications are as follows:
-
Glaucoma with normal pressure,
-
Scleral thinning or ectasia,
-
Eye tumour,
-
Eye infection,
-
Anatomy of the eye non-compatible with
the positioning of the device on the
patient’s eye (too narrow
palpebral eyelid,
buphthalmic eye, etc),
-
Thyroid orbitopathy,
-
Choroidal hematoma,
-
Aphakic patient,
-
Presence of a valve, tube, or any other
element on the eye surface preventing
proper positioning on the patient’s eye (ex:
chemosis caused by the anesthesia, scaring
filtration bleb after filtering surgery, etc).
-
Patient’s history of retinal detachment,
macular edema, choroidal hematoma,
and/or uveitis.
Practitioner is asked to not treat under these conditions.
Precautions:
➢
A second treatment may be necessary to reach the targeted IOP below 21 mmHg.
➢
There are no contraindications to conducting a second ultrasound treatment procedure. No increased
occurrence of side effects related to retreatment has been reported. The interval between two
treatments is left to the judgment of the qualified practitioner.
2.3
Poor indications
Pathologies or patient’s history for which the treatment with the medical device
may have a limited efficacy
and/or may induce higher risk of complications are as follow:
-
Diabetic patient with or without diabetic -
retinopathy,
-
Retinal vein occlusion,
-
Vitrectomy,
-
Multiple intra vitreous injections,
-
Age-related Macular Degeneration (AMD),
especially the exudative form,
-
High myopia.
Note:
Knowing the results of the clinical studies on secondary glaucoma (neovascular, pigmentary, pseudo-
exfoliative, etc), the patient’s response rate is lower than for primary open angle and angle closure gl
aucoma.
The responsibility to treat patients with these poor indications with the medical device is left to the judgement
of the qualified practitioner
.