Sutureless Glueless Technique Versus Interrupted Suturing for Conjunctival Autograft Fixation After Primary Pterygium Excision: Anterior Segment Optical Coherence Tomography (ASOCT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient-reported discomfort (VAS 0-10) - Secondary
研究概览
简要总结
This study aims to compare the clinical and Anterior segment optical coherence tomography (ASOCT) outcomes between sutured and sutureless conjunctival autograft fixation techniques in the management of primary pterygium.
A total of 30 patients with bilateral primary pterygia were included. Each patient underwent pterygium excision in both eyes: one eye received graft fixation using interrupted 10-0 nylon sutures, while the fellow eye received sutureless fixation. Allocation of technique between eyes was randomized.
All surgeries were performed by the same surgeon, and patients were followed up weekly for one month. Parameters assessed included graft thickness, interface reflectivity, gutter size, conjunctival congestion, donor site healing, and postoperative discomfort using a visual analogue scale.
The study evaluates which fixation method provides faster healing, better cosmetic results, and fewer complications such as graft slippage or recession, especially in relation to pterygium size.
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
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years (both sexes). Diagnosis of bilateral primary nasal pterygium requiring surgical excision (both eyes affected).
- •Horizontal corneal encroachment of the pterygium ≥ 2.0 mm in each eye. Lesions amenable to conjunctival autograft coverage with expected graft size obtainable from superior bulbar conjunctiva.
- •Willingness and ability to attend scheduled follow-up visits for 1 month postoperatively.
- •Able to provide written informed consent.
排除标准
- •Recurrent pterygium in either eye. Previous ocular surgery on the study eye(s) (including prior pterygium surgery) or conjunctival grafting.
- •Active ocular surface disease or infection (e.g., conjunctivitis, keratitis) at screening.
- •Severe dry eye disease (e.g., Schirmer's test ≤ 5 mm or TBUT < 5 s) likely to affect healing.
- •Significant ocular comorbidities affecting wound healing or outcome interpretation: uncontrolled glaucoma with conjunctival filtering surgery, ocular surface cicatrizing disorders (e.g., ocular pemphigoid), severe blepharitis, or severe meibomian gland dysfunction.
- •Systemic conditions that impair wound healing or increase surgical risk (e.g., uncontrolled diabetes mellitus with HbA1c > 8.0%, connective tissue disorders, immunosuppression, chronic systemic corticosteroid use).
- •Current use of anticoagulant therapy that cannot be safely paused per local perioperative protocol (if this precludes safe graft fixation).
- •Pregnancy or breastfeeding. Known allergy to any material used in the procedure or postoperative medications.
- •Inability to comply with follow-up schedule or provide informed consent (e.g., cognitive impairment, planning to move away).
结局指标
主要结局
Patient-reported discomfort (VAS 0-10) - Secondary
时间窗: Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4
Mean Visual Analogue Scale (0 = no discomfort to 10 = worst possible) recorded at each visit.
Graft stability: incidence of slippage or recession (%) - Secondary (Safety/Complication)
时间窗: Time Frame: Within 1 month postoperatively
Proportion of eyes with clinically significant graft slippage or marginal recession requiring intervention or observed during follow-up.
Cosmetic outcome - surgeon-rated score (0-10)
时间窗: Time Frame: 4 weeks (Month 1) postoperatively
Surgeon's cosmetic grading based on redness, graft contour and surface smoothness (0 = poor to 10 = excellent).
次要结局
- Interface reflectivity (qualitative grading: low/moderate/high)(Time Frame: Week 1, Week 2, Week 3, Week 4)
- Change in central graft thickness (µm) -(Baseline (Day 1) to Week 4)
- Gutter size at graft-host junction (µm)(Time Frame: Week 1, Week 2, Week 3, Week 4)
- Donor site epithelialization (complete: Y/N and time to healing in days) - Secondary(Time Frame: Assessed weekly up to 4 weeks)
- Mean central graft thickness measured by AS-OCT (µm)(Time Frame: 4 weeks (Month 1) postoperatively)
- Conjunctival congestion score (0-3)(Time Frame: Day 1, Week 1, Week 2, Week 3, Week 4)
- Early recurrence (clinical evidence of fibrovascular regrowth at limbus) -(Time Frame: 4 weeks (Month 1) postoperatively)
- Operative time (minutes) - Secondary(Time Frame: At surgery (intraoperative))
- Adverse events (type and severity) - Secondary (Safety)(Time Frame: Within 1 month postoperatively)
研究者
Mahmoud Ramadan
lecturer of ophthalmolgy
Minia University