Glaucoma, Canaloplasty, Trabeculectomy
Conditions
Keywords
trabeculectomy,, canaloplasty,, glaucoma surgery, non-penetrating surgery
Brief summary
Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.
Interventions
PROCEDUREtrabeculectomy
trabeculectomy with mitomycin C 0.2mg/ml
PROCEDURECanaloplasty
Canaloplasty with implant of suture
Sponsors
University Eye Hospital, Würzburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosed primary or secondary open-angle glaucoma 2. IOP \> 16 mmHg (\<60 days prior surgery) 3. IOP \> 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed
Exclusion criteria
1. angle closure glaucoma 2. congenital glaucoma 3. combined procedures (glaucoma and cataract)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success rate (complete and qualified success) | 1 year | Success is defined 1. IOP \< 21 mmHg and at least 20% IOP reduction from baseline 2. IOP \< 18 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP, medication, complications | 1 year | intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively |
Countries
Germany
Outcome results
None listed