Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
Condition: Recurrent Pterygium of Eye; Steroid-Induced Glaucoma
MeSH terms: Pterygium; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to evaluate the efficacy of topical 0.2% loteprednol
      etabonate, a 'soft steroid', compared with topical 0.1% dexamethasone, which is widely used
      in postoperative pterygium excision to prevent the recurrence of pterygium. If 0.2%
      loteprednol etabonate is non-inferior in efficacy compared with 0.1% dexamethasone, it may be
      used postoperatively in pterygium excision patients with the benefit of a low incidence of
      ocular hypertension or secondary glaucoma.
    

Detailed description: 
      A prospective randomized control trial was performed from October 2015 to April 2019 at the
      Department of Ophthalmology, Thammasat Hospital, Thailand and Panyananthaphikkhu Chonprathan
      Medical Center, Thailand.

      Subjects Patients who had pterygium excision with amniotic membrane transplantation (AMT) and
      who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading
      the cornea were included.

      Then the participants were randomized into 2 groups. Both groups received subconjunctival
      5-fluorouracil (5-FU) injection 5mg/0.1 mL with 27-gauge needle in the area of fibrovascular
      tissue, and then the eyes were irrigated with 30 mL of normal saline. 0.2% loteprednol
      etabonate was prescribed in group 1, and 0.1% dexamethasone (CD-oph) was prescribed in group
      2 every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until
      cessation at 3 months. 5-FU was repeatedly injected monthly in the presence of marked
      inflammation and not more than 3 times to prevent complications.

      All patients were followed-up at 1, 3, 6, and 9 months to assess the impending recurrent
      pterygium severity score, intraocular pressure, complications, detection of true recurrent
      pterygium, and time to recurrence.
    

Intervention name(s): 0.2% loteprednol etabonate; 0.1% dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Use topical 0.2% loteprednol etabonate eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.; Use topical 0.1% dexamethasone eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
Other intervention name(s): Alrex; CD-oph
Intervention MeSH terms: Loteprednol Etabonate; Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were randomized into 2 groups. Group 1 were treated with subconjunctival 5-FU injection and topical 0.2% loteprednol etabonate while group 2 were treated with subconjunctival 5-FU injection and topical 0.1% dexamethasone (CD-oph: dexamethasone sodium phosphate 1 mg/mL, chloramphenicol 5 mg/mL, tetrahydrozaline hydrochloride 0.25 mg/mL).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impending recurrent pterygium; 0.2% loteprednol etabonate; 0.1% dexamethasone