Efficacy and Safety of the ELIOS Laser in Combined Cataract and Glaucoma Surgery
ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHôpital Privé de la Baie
About this trial
Glaucoma is an irreversible optic neuropathy. It is the second most common cause of blindness worldwide. Glaucoma can be treated with topical medications (eye drops), laser or surgery. Traditional surgery is invasive and has a high complication rate (hypotonia, endophthalmitis, cataracts, etc.). As a result, several types of micro-invasive surgery (MIGS) have been developed to reduce the risks of surgery while maintaining their effectiveness in lowering intraocular pressure (IOP). The ELIOS laser system is the only ophthalmological excimer laser designed for the surgical treatment of glaucoma. The aim of the procedure is to ablate the trabecular meshwork and inner wall of Schlemm´s canal ab interno, with the creation of 10 microchannels of 210 um in the trabeculum using the ELIOS laser with a wavelength of 308 nm, in order to improve trabecular outflow to achieve a reduction in IOP. The ELIOS laser is an example of Microinvasive Glaucoma surgery (MIGS) with published results demonstrating efficacy and safety. The ELIOS laser is already in use in France (AMM / CE mark achieved). Its use as part of a prospective interventional study will enable us to collect data in order to treat patients more effectively and improve the quality of care provided to glaucoma patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age who agree to take part in the study and have signed an informed consent form
Visually significant cataract with indication for surgery
Primary open-angle glaucoma, or secondary open-angle glaucoma (pseudoexfoliative glaucoma or pigmentary glaucoma) with indication for cataract surgery.
Open iridocorneal angle (Shaffer classification grade 2-4)
Disqualifiers
Presence of severe systemic pathologies 2024-A01891-46_Protocol_V6_21112024_Elios Page 20 / 58
Pregnant or breastfeeding women
<18 years of age
Presence of other ophthalmological pathologies (except cataracts), and exclusion of severe dry eye.
Trial design
Design model
Single group
Treatments tested in this trial
Surgery with ELIOS laser
DeviceThis surgery involves visualizing the iridocorneal angle before or after cataract surgery, inserting the ELIOS laser probe into the anterior chamber to come into slight contact with the trabecular meshwork, then pressing the foot pedal, the surgeon activates the laser, which creates a microchannel by photoablating the trabecular meshwork and inner wall of Schlemm´s canal (trabeculostomy) ± 210 um in diameter. This gesture is repeated until 10 microchannels are created. The creation of these microchannels enhances the natural outflow of aqueous humor by bypassing the site of major resistance in the system. The usual duration of the ELIOS procedure is typically few minutes). The rest of the surgery does not deviate from standard phacoemulsification.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: EliosExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intraocular pressure (IOP)
This IOP measurement will be carried out using the Goldmann gold standard tonometer, in 2 measurements taken between 8am and 12am, and measured in mmHg
Time frame
day 0, 7 and 30, and month 3, 6 and 12 months after surgerySecondary outcomes
1
Quality of life
A quality of life questionnaire : 25 questions with Likert scales
Time frame
before and after surgery (1, 3, 6 and 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov