Cataract, Normal Tension Glaucoma
Conditions
Keywords
endoscopic cyclophotocoagulation, ECP, Surgery
Brief summary
The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.
Detailed description
Subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.
Interventions
PROCEDUREPhaco
phacoemulsification of cataract only
PROCEDUREPhaco+ECP
Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Succes rate | One year postoperatively | Success: Decrease in Intraocular Pressure (IOP) of 20 % or more or former level with fewer medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional surgery | Five years postoperatively | Comparison of the need for additional glaucoma surgery |
Countries
Finland
Contacts
Primary ContactNina M Lindbohm, MD, PhD
Outcome results
None listed