MIGS VS SLT Comparison in Glaucoma Patients

MIGS VS SLT in Glaucoma Patients: Prospective Study

To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Device: MIGS Hydrus Ivantis; Procedure: 360 degrees SLT

Detailed Description

Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.

Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10138
    • Ophthalmology Institute, University of Turin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy

Exclusion Criteria:

• eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIGS Hydrus Ivantis; opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control	Device: MIGS Hydrus Ivantis; implant of the micro stent in the nasal Schlemm's canal
Experimental: SLT; Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ	Procedure: 360 degrees SLT; Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the intraocular pressure compared to baseline	measurement with GAT in mm Hg	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the number of glaucoma medications compared to baseline	accountability of IOP lowering medications used by the patient	up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of visual acuity compared to baseline	ETDRS visual acuity scale	6 months and 1 year post-intervention
change of visual field compared to baseline	MD and PSD	1 year post-intervention

Collaborators and Investigators

• Sponsor: University of Turin, Italy
• Collaborators: University of Siena
• Investigators: Principal Investigator: Antonio Fea, MD, Clinica Oculistica

Publications and helpful links

General Publications

• Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 19, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: MIGS; SLT
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)