Preoperative Intra-lesional Bevacizumab Injection in Primary Pterygium in Tunisian Patients: A Randomized Controlled Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of recurrence
研究概览
简要总结
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.
详细描述
This prospective randomized controlled study adhered to the tenets of the Declaration of Helsinki. The Ethics Committee of our institution approved its modalities. The investigators had informed consent from all participants. The study included a total of 60 eyes of 60 patients with primary pterygium between January 2019 and December 2020. The investigators divided the patients into two groups of 30 patients each. The investigators performed a simple randomization method using a table of random numbers. Group A received an intralesional injection of 0.05 ml (1.25 mg) of Bevacizumab, one month before surgical treatment (lesion excision and conjunctival autograft by a single trained surgeon). Group B (control) had only the surgical treatment.
Each patient underwent a complete ocular examination: BSCVA, refraction, slit-lamp biomicroscopy, fundoscopy, and intraocular pressure measurement.
The investigators classified pterygium according to its stage (the Vaniscotte et al. Classification), grade (according to Tan et al. grading scheme), and color intensity (according to Teng et al : 0 = unremarkable, 1 = trace, 2 = mild, 3 = moderate, 4 = diffuse). The investigators measured Its corneal surface with Image J software. The study included patients over 18-years-old having primary pterygium with surgical indications:
- Stages 2, 3 and 4
- Significant astigmatism > 1.50 PD
- Patients with significant functional signs: according to a discomfort score that The investigators proposed.
Non-inclusion criteria were recurrent pterygium, suspected pterygium (sentinel vessels, resistant inflammation), and filtering surgery indication. Excluded were patients lost to follow-up or having a bevacizumab contraindication (hypertension, bleeding tendencies, previous myoredial infarction or stroke, pregnant and lactating women).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of primary pterygium (stages 2,3 and 4) with surgical indication.
排除标准
- •unable to attend the whole follow-up
- •Bevacizumab contraindications (hypertension, bleeding tendencies, previous myocardial infarction or stroke, pregnant and lactating women).
研究组 & 干预措施
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.
干预措施: Preoperative Intra-lesional Bevacizumab Injection in primary pterygium (Drug)
pterygium excision+ autograft
Patients undergoing only pterygium surgical treatment.
干预措施: pterygium surgery without adjunctive therapy (Procedure)
结局指标
主要结局
Incidence of recurrence
时间窗: 6 months post-operatively
growth of fibrovascular tissue extending more than 1 mm across the limbus.
Rate of functional discomfort following intralesional bevacizumab injection
时间窗: 6 months post-operatively
The subjective variables: 1) photophobia; 2) foreign body sensation; 3) Ocular itching; 4) tearing; 5) ocular redness; and 6) visual blurring, were evaluated according to their severity from 0 to 10 (visual analogue scale (VAS)).
次要结局
- % of patients with change in morphology of pterygium after injection(one month)
- Rate of mean changes from baseline in BCSVA(6 months post-operatively)
- Rate of mean changes from baseline in astigmatism(6 months post-operatively)
研究者
Khairallah Moncef
Professor
University Hospital Fattouma Bourguiba