The Clinical Outcome of Full Digital Fabricated Ocular Prosthesis Versus Conventional Fabricated Technique (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Motility of ocular prosthesis
研究概览
简要总结
Different techniques of fabricating conventional custom-made ocular prosthesis were described. Traditional methods of custom fabricated ocular prosthesis had some limitations and take a long time, facial scanning and computed tomography will facilitate the full digital ocular prosthesis fabrication. Full digital ocular prosthesis is an innovated new technique to produce more accurate & more esthetic ocular prosthesis with less time consumed, however very few articles are available comparing between the full digital technique & the conventional one in manufacturing ocular prosthesis.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have enough ocular bed to accommodate the ocular prosthesis.
- •At least 3 months after surgery to allow complete healing of the socket.
排除标准
- •Patients under steroid therapy or those under radio or chemotherapy.
- •Patients having eye lid deformity.
- •History of psychological disorder.
- •systemic disease.
- •eye infection.
结局指标
主要结局
Motility of ocular prosthesis
时间窗: Time of insertion
Using Matlab R2016b software+. For each patient, photos of different eye positions will be taken, namely, the frontal, upper, lower, left, and right viewing positions.
Change in patient satisfaction
时间窗: Time of insertion and 3 months
Patient satisfaction will be evaluated by questionnaire based on the UK National Artificial Eye Questionnaire (NAEQ). The items that will be evaluated in the questionnaire include Time taken to adjust the prosthesis, Prosthesis cleaning frequency, Lubrication frequency, Comfort rating, satisfaction with prosthetic appearance, and satisfaction with prosthetic motility
change in microbial analysis
时间窗: Time of insertion and 3 months
Patients will attend 2 visits (0,3 month), in which swab will be collected from the internal surface of the ocular prosthesis as well as from the anophthalmic cavit
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University