Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Clinical Trial: Comparison of the Efficacy of Topical 0.2% Loteprednol Etabonate and Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

Conditions
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Recurrent Pterygium of Eye, Steroid-Induced Glaucoma

Intervention / Treatment
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* Drug: 0.2% loteprednol etabonate
* Drug: 0.1% dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.2% loteprednol etabonate<br>This group was treated with subconjunctival 5-FU injection and topical 0.2% loteprednol etabonate every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months. | Drug: 0.2% loteprednol etabonate<br>* 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.<br>* Other names: Alrex;|
| Active Comparator: 0.1% dexamethasone<br>This group was treated with subconjunctival 5-FU injection and topical 0.1% dexamethasone (CD-oph) every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months. | Drug: 0.1% dexamethasone<br>* 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.<br>* Other names: CD-oph;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of true recurrent pterygium | true recurrent pterygium is the fibrovascular tissue that invade into cornea | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity score of impending recurrent pterygium | severity score of impending recurrent pterygium included 3 factors; redness, thickness of fibrovascular tissue, and size of fibrovascular tissue at 3 mm from limbus, which are classified into 3 grades in each factor. | 6 months | 
| time to recurrent of pterygium | time from enrolled participants until they developed true recurrent pterygium | 6 months | 
| rate of steroid induced ocular hypertension | number of participants in each group who had intraocular pressure > 21 mmHg | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impending recurrent pterygium, 0.2% loteprednol etabonate, 0.1% dexamethasone