Preoperative Bevacizumab Injection in Primary Pterygium in Tunisian Patients

Conditions

• Pterygium

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Preoperative Intra-lesional Bevacizumab Injection in primary pterygium — DRUG
  The surgical technique featured: subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture Any intraoperative complication was noted and was treated accordingly. All patients received dexamethasone + tobramycin eye drops postoperatively 4 times a day in the 1st week. The eye drops were tapered over 4 weeks. Patients were examined 30 days before bevacizumab injection (D-30), before surgery (day 0: D0) and then at D7, M1, M3, and M6 after surgery.
• pterygium surgery without adjunctive therapy — PROCEDURE
  The surgical technique featured: subconjunctival anesthetic (lidocaine 2%) injection 5 mm from limbus; excision of the pterygium, starting from its head, followed by pterygium body removal; exposition of a triangular-shaped bare scleral bed (3-4 mm) conjunctival autograft stitched limbus to limbus with 10/0 vicryl suture

Study Details

Purpose: To assess the efficacy and safety of a single preoperative intra-lesional bevacizumab injection in primary pterygium. Methods: The investigators conducted a randomized controlled interventional study from January 2019 to December 2020. The study included a total of 60 patients (60 eyes) with primary pterygium. The investigators defined two groups of 30 patients each. Group A received an intralesional injection of bevacizumab (Avastin), one month before surgery (lesion excision and conjunctival autograft). Group B (control) had only the surgical treatment. Patients were followed up seven days (D7), one month (M1), three months (M3), and six months (M6) post-operatively. Pre-, per- and post-operatively, photographs of the lesions were taken, as well as a pathological examination. The main outcome measures were the change in functional discomfort following intralesional bevacizumab injection and pterygium recurrence. Recurrence was defined by fibrovascular tissue growth extending more than 1 mm across the limbus. Therapeutic success was defined as the absence of pterygium recurrence in M6.

Key Dates

First listed

Apr 6, 2022

Start date

Jan 1, 2019

Status verified

Apr 2022

Primary completion

Jan 1, 2021

Completion

Jan 1, 2021

Study Design

Enrollment

60 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Preoperative intralesional injection of bevacizumab + pterygium excision+ autograft
  Patients receiving intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment. Surgical treatment consisted of lesion excision and conjunctival autograft performed by a single trained surgeon.
• Active Comparator: pterygium excision+ autograft
  Patients undergoing only pterygium surgical treatment.

Primary Outcome Measure

Incidence of recurrence [ Time Frame: 6 months post-operatively ]