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OpenTrials
Completed

NCT Number: NCT02789293

Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients

The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven - University Hospital, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
  • Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
  • Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and <30 mmHg
  • No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
  • Age > 18 years and < 90 years
  • Patient able and willing to complete postoperative follow-up requirements

Exclusion criteria

  • Patient who has been diagnosed for normal tension glaucoma
  • Ocular or retrobulbar tumor
  • Ocular infection within 14 days prior to the HIFU procedure
  • Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema…)

Treatment and study plan

EyeOP1 device

Device

Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound

Primary outcomes

  1. Efficacy endpoint : Reduction of intraocular pressure

    Time frame: 24 months

    Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months

Secondary outcomes

  1. Safety : rate of per and post-operative complications/adverse effects

    Time frame: 24 months

    rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits

  2. Efficacy endpoint : Mean IOP (mmHg)

    Time frame: 24 months

    Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)

  3. Efficacy Endpoint : Mean IOP variation (%)

    Time frame: 24 months

    Mean IOP variation (%) at each visit during the follow-up period

  4. Mean Number of ocular hypotensive medications

    Time frame: 24 months

    Mean number of ocular hypotensive medication at each visit during the followup period

Sponsors and collaborators

Lead sponsor

EyeTechCare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jun 2, 2016
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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