Combining endoscopic cyclophotocoagulation with cataract surgery for normal tension glaucoma
Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
NA · Helsinki University Central Hospital · NCT04651530
This study is testing if adding a special eye treatment during cataract surgery can help people with normal tension glaucoma lower their eye pressure better than cataract surgery alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital (other) |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT04651530 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding endoscopic cyclophotocoagulation (ECP) to cataract surgery in patients with normal tension glaucoma. Participants with stable glaucoma who require cataract surgery will be randomly assigned to receive either ECP during their cataract surgery or cataract surgery alone. The primary goal is to determine if the combination procedure results in lower intraocular pressure compared to cataract surgery by itself. The study aims to provide insights into improving treatment outcomes for patients with this specific type of glaucoma.
Who should consider this trial
Good fit: Ideal candidates are individuals with stable normal tension glaucoma and clinically significant cataracts who are currently on medication.
Not a fit: Patients with secondary glaucoma or those who have had previous glaucoma surgeries are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of intraocular pressure in patients with normal tension glaucoma undergoing cataract surgery.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 stable with current medication assessed by a glaucoma specialist * Clinically significant cataract 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 * Cataract due to eye injury or congenital cataract * Zonular weakness due to Marfan syndrome or other * 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 glaucoma progresses on current IOP * The patient does not speak Finnish, Swedish or English * Dementia * Only eye with vision worse than 20/200 or loss of central visual field
Where this trial is running
Helsinki
- Helsinki University Hospital — Helsinki, Finland (RECRUITING)
Study contacts
- Principal investigator: Mika Harju, MD, PhD — Helsinki University Central Hospital
- Study coordinator: Nina M Lindbohm, MD, PhD
- Email: nina.lindbohm@hus.fi
- Phone: +358505715668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Normal Tension Glaucoma, Cataract, endoscopic cyclophotocoagulation, ECP, Surgery