Clinical trial NCT04075227: Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
Official title: A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Pterygium of Eye
Steroid-Induced Glaucoma
Keywords: Impending recurrent pterygium
0.2% loteprednol etabonate
0.1% dexamethasone
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
Collaborators: name: Srinakharinwirot University
First posted: 2019-08-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients who had pterygium excision with amniotic membrane transplantation and who had impending recurrent pterygium stage 3 defined as fibrovascular tissue not invading the cornea

Exclusion Criteria:

* recurrent pterygium
* received adjunctive treatment with beta radiation, mitomycin C or 5-fluorouracil
* glaucoma or intraocular pressure \> 21 mmHg
* history of 5-fluorouracil or chloramphenicol allergy

Primary outcomes:
measure: rate of true recurrent pterygium
timeFrame: 6 months
Secondary outcomes:
measure: severity score of impending recurrent pterygium
timeFrame: 6 months
measure: time to recurrent of pterygium
timeFrame: 6 months
measure: rate of steroid induced ocular hypertension
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Srinakharinwirot University
name: Wannisa Suphachearabhan, MD
role: PRINCIPAL_INVESTIGATOR
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