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Search / Trial NCT05371977

Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · May 10, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is comparing two surgical procedures, deep sclerectomy and trabeculectomy, to see which one is better at lowering eye pressure in patients with normal tension glaucoma. Normal tension glaucoma is a type of eye condition where damage occurs to the optic nerve without high eye pressure, which can lead to vision loss. The study aims to find out if deep sclerectomy is just as effective as trabeculectomy for controlling eye pressure in these patients.

To participate in this trial, individuals must have been diagnosed with normal tension glaucoma and have specific signs of the disease confirmed by eye tests. They should also be experiencing unstable glaucoma despite using medication. It’s important to note that certain conditions, like previous eye surgeries or other eye diseases, may exclude someone from joining. If eligible, participants can expect to receive one of the two surgical treatments and will be monitored to see how well their eye pressure is controlled after the procedure. The trial is currently looking for volunteers of all genders, aged between 18 and 30 years.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Signed Informed Consent
  • Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
  • Glaucoma unstable with current medication assessed by a glaucoma specialist
  • Exclusion Criteria:
  • Secondary Glaucoma e.g. due to previous injury or uveitis
  • Exfoliation syndrome
  • Pigment dispersion syndrome
  • Previous transscleral or endoscopic cyclophotocoagulation
  • Previous other glaucoma surgery
  • Previous retinal detachment
  • Previous intraocular surgery like vitrectomy and other retinal surgery
  • Wet age-related macular degeneration
  • Diabetic retonopathy
  • Previous corneal transplant or previous refractive surgery
  • Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
  • The patient does not want to participate in the study
  • The patient does not speak Finnish, Swedish or English
  • Dementia
  • Only eye with vision worse than 20/200 or loss of central visual field

About Helsinki University Central Hospital

Helsinki University Central Hospital (HUCH) is a leading academic medical institution in Finland, dedicated to advancing healthcare through innovative research and clinical excellence. As a pivotal sponsor of clinical trials, HUCH integrates cutting-edge medical practices with rigorous scientific inquiry, fostering collaborations between researchers, healthcare professionals, and patients. The hospital is committed to enhancing patient outcomes and contributing to the global body of medical knowledge by conducting high-quality, ethically sound clinical studies across a diverse range of therapeutic areas. With a strong emphasis on education and training, HUCH plays a vital role in shaping the next generation of healthcare leaders and researchers.

Locations

Helsinki, , Finland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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