Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.

Sponsor
Medical University of Lublin
Study ID
NCT03766425
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Eye Diseases
  • Glaucoma Surgery
  • Optic Nerve Damage

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    subconjunctival injection
  • Mitomycin — DRUG
    subconjunctival injection

Study Details

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.

Key Dates

Start date
Jun 14, 2017
Status verified
Oct 2023
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept
    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.
  • Active Comparator: Mitomycin
    Mitomycin applied during a surgery at a concentration of 0.3mg / ml for 3 min. on a soaked sponge.

Primary Outcome Measure

Effectiveness of aflibercept and mitomycin on the morphology of the bleb; [ Time Frame: 1 year ]

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