RECRUITING

A Trial of Hydrus Microstent Versus Goniotomy

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Conditions

GlaucomaGlaucoma, Open-AngleIncisional goniotomyExcisional goniotomyHydrus MicrostentGoniotomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are: * How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare? * How do the safety profiles of these three microinvasive glaucoma surgeries compare? Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.

Official Title

Randomized Trial of Hydrus Microstent Versus Goniotomy

Quick Facts

Study Start:2025-02-14
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06289491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Visually significant cataract planned for surgery
  2. * Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
  3. * Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees \<15 dB
  4. * Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points \<15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point \<15 dB
  5. * Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
  6. * Willing and able to understand and provide informed consent
  7. * Willing and able to attend postoperative examinations per protocol schedule
  1. * Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
  2. * Selective laser trabeculoplasty within 90 days of study enrollment
  3. * Iridotrabecular contact for 180 degrees or greater
  4. * Peripheral anterior synechiae in nasal or inferior angle
  5. * Best corrected visual acuity worse than 20/200
  6. * Phacodonesis on pre-operative examination
  7. * Vitreous in anterior chamber on pre-operative examination
  8. * Nanophthalmos
  9. * Anti-platelet and anticoagulant medications other than aspirin 81mg daily
  10. * Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
  11. * Abnormality in study eye that could affect tonometry
  12. * Glaucoma diagnosis other than the above
  13. * Normal tension glaucoma
  14. * Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
  15. * History of uveitis in either eye
  16. * Inability to complete gonioscopy examination
  17. * Use of oral steroids within 90 days or anticipated use of oral steroids
  18. * Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide
  19. * History of steroid-associated IOP elevation
  20. * Medically unfit for attending planned study visits
  21. * Involvement in another interventional research study

Contacts and Locations

Study Contact

Michael M Lin, MD
CONTACT
617-936-6082
michael_lin@meei.harvard.edu

Study Locations (Sites)

Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-14
Study Completion Date2029-04

Study Record Updates

Study Start Date2025-02-14
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • Incisional goniotomy
  • Excisional goniotomy
  • Hydrus Microstent
  • Goniotomy

Additional Relevant MeSH Terms

  • Glaucoma
  • Glaucoma, Open-Angle