Primary Open-Angle Glaucoma Glaucoma Glaucoma, Open-Angle Trabeculectomy Mitomycin Intraocular Pressure Filtering Surgery Antimetabolites Randomized Controlled Trials as Topic
Conditions
Interventions
Patients undergo standard trabeculectomy with intratenon Mitomycin C injection. Mitomycin C 0.2 mg/ml, 0.2 ml is mixed with 2 percent lidocaine hydrochloride, 0.2 ml, resulting in a final Mitomycin C
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Trabeculectomy with Mitomycin C Sub-Tenon Injection,Trabeculectomy with Mitomycin C Soaked Sponge
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older. 2. Diagnosed with primary open-angle glaucoma requiring trabeculectomy due to inadequate intraocular pressure control despite appropriate medical treatment. 3. Eligible for trabeculectomy with Mitomycin C augmentation. 4. Able to attend all scheduled postoperative follow-up visits for 6 months. 5. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Glaucoma types other than primary open-angle glaucoma, including angle-closure glaucoma, congenital glaucoma, juvenile glaucoma, neovascular glaucoma, and uveitic glaucoma. 2. Previous glaucoma surgery in the study eye. 3. Previous ocular surgery that may influence trabeculectomy outcomes, including filtering surgery or tube shunt implantation. 4. Ocular conditions that may interfere with outcome assessment, including corneal opacity affecting intraocular pressure measurement, active ocular infection, ocular inflammation, or severe ocular surface disease. 5. Severe uncontrolled systemic disease that may impair wound healing. 6. Inability or unwillingness to comply with follow-up visits or a high likelihood of loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure 6 months after surgery Mean intraocular pressure measured in mmHg using Goldmann applanation tonometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Glaucoma Medications 1 week, 1 month, 3 months, and 6 months after surgery Number of intraocular pressure lowering medications used after surgery,Filtering Bleb Morphology 1 week, 1 month, 3 months, and 6 months after surgery Bleb height, extent, vascularity, and Seidel test assessed using the Indiana Bleb Appearance Grading Scale,Visual Acuity 1 week, 1 month, 3 months, and 6 months after surgery Best corrected visual acuity assessed by standard ophthalmic examination,Postoperative Complications Within 1 month after surgery Incidence of hypotony, bleb leak, thin avascular bleb, and bleb related infection,Postoperative Interventions Within 6 months after surgery Frequency of postoperative interventions including laser suture lysis, bleb needling, bleb revision, and other additional procedures,Surgical Success 1 month, 3 months, and 6 months after surgery Complete success, qualified success, and surgical failure based on predefined intraocular pressure control criteria | — |
Countries
Thailand
Contacts
Public ContactPattana Poopattanakul
Somdejphrajaotaksinmaharaj Hospital
Outcome results
None listed