Glaucoma, Glaucoma Eye
Conditions
Keywords
ptosis, combined procedures, glaucoma, post-surgery complication
Brief summary
The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea. This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.
Detailed description
The way of the intraoperatively fixation may have some impact for postoperative results of the level of intraocular pressure (IOP), visual acuity (BCVA) and the incidence of upper eyelid ptosis was determined as a post-operative MRD (margin reflex distance) ≥2mm.
Interventions
PROCEDUREcombined glaucoma surgery
combined procedure with trabeculectomy and cataract removal
Sponsors
Medical University of Bialystok
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective randomized trial with a 6 month follow-up period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacities Classification System III) * primary open-angle glaucoma and secondary pseudoexfoliative glaucoma, in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic * documented progression of loss of field of vision * significant daily IOP fluctuations * no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medications
Exclusion criteria
* no consent to participation in the study * prior surgical and laser procedures in the area of the eye * narrow- or closed-angle glaucoma * post-inflammatory or post-traumatic secondary glaucoma * chronic illness of the cornea or optic nerve * advanced macular degeneration * active inflammatory process * pregnancy * systemic steroid therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP | baseline and twelve months after surgery | the change in the level of intraocular pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA | baseline and twelve months after surgery | the change in the best corrected visual acuity |
| MRD | baseline and twelve months after surgery | the incidence of upper eyelid ptosis determined as a post-operative MRD (margin reflex distance) ≥2mm |
Countries
Poland
Outcome results
None listed