Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.
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|ClinicalTrials.gov Identifier: NCT03766425|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eye Diseases Optic Nerve Damage Glaucoma Surgery||Drug: Aflibercept Drug: Mitomycin||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy - a Prospective, Randomized Trial in Patients With Open-angle Glaucoma Undergoing Surgery.|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Aflibercept applied intraoperatively as a subconjunctival injection at a dose of 0.05 ml (40 mg / ml) and one week after the operation at the same dose, also subconjunctival.
Other Name: Eylea, Zaltrap
Active Comparator: Mitomycin
Mitomycin applied during a surgery at a concentration of 0.3mg / ml for 3 min. on a soaked sponge.
Other Name: Ametycine, Mit-C, Mitomycin C
- Effectiveness of aflibercept and mitomycin on the morphology of the bleb; [ Time Frame: 1 year ]Rating the bleb in The Indiana Bleb Appearance Grading Scale, describing bleb height, extent, vascularity, and leakage with the Seidel test.
- Effectiveness of aflibercept and mitomycin on the function of the bleb; [ Time Frame: 1 year ]Measurement of intraocular pressure (Goldmann applanation tonometer) and taking a photo of a bleb.
- Impact of tested substances on visual acuity after surgery [ Time Frame: 1 year ]Examination of a visual acuity 1 week after operation as well as 1 month, 3 months, 6 months, 12 months
- The influence of aflibercept and mitomycin on corneal endothelial cell density after surgery [ Time Frame: 1 year ]Examination of the corneal endothelial cell density before the surgery as well as 6 months and 12 months after surgery
- Impact of used substances on visual field parameters [ Time Frame: 1 year ]Examination of a visual field in SITA (Swedish Interactive Testing Algorithm) FAST strategy before the surgery and 12 months after surgery
- Frequencies and type of possible complications. [ Time Frame: 1 year ]observing and recording all complications and side effects in both groups of patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766425
|Medical University of Lublin|
|Lublin, Lubelskie, Poland, 20-059|