Comparison of Peroperative Methotrexate Infusion With Postoperative Intra Silicon Oil Methotrexate Injections for Prevention of Proliferative Vitreoretinopathy Development After Vitrectomy for Rhegmatogenous Retinal Detachment Repair.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Development of Proliferative Vitreoretinopathy (PVR)
研究概览
简要总结
This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups.
详细描述
This interventional trial will be conducted at the Sahiwal Teaching Hospital, Sahiwal and Ali Fatima Teaching Hospital Lahore from March 2024 to May 2025. The study will follow the guidelines of the Declaration of Helsinki. The study protocol will be approved by institutional review boards of respective hospitals. Written informed consent will be taken from all the subjects. The first subject will be recruited in March 2024 and the last subject will be recruited in February 2025. Three more months will be required to complete the final follow-up of the last subject.
The study will include rhegmatogenous retinal detachments patients of both sexes between 20 and 70 years of age.
Exclusion criteria will include the presence of proliferative vitreoretinopathy grade C, previous retinal detachment surgery in the same eye, penetrating ocular trauma, intraocular foreign bodies, and pregnant and lactating women.
A detailed history of the patients' presenting complaints, duration of symptoms, and risk factors for retinal detachment will be gathered. Comprehensive ocular examination, including visual acuity, intraocular pressure, and examination of the anterior and posterior segments, will be performed. The extent of retinal detachment, location of retinal breaks, and presence of PVR will be documented.
Sampling method will be simple random sampling. Using lottery methods patients will be divided into two groups with 60 subjects in each group. Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution. Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd , 4th and 6th post operative weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
This will be a single-blind study in which the subjects will be unaware of the intervention. Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they are receiving.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rhegmatogenous Retinal Detachment
排除标准
- •Presence of proliferative vitreoretinopathy grade C, previous retinal detachment surgery in the same eye, penetrating ocular trauma, Presence of intraocular foreign bodies, previous glaucoma filtration surgery, allergy to methotrexate, and pregnant and lactating women.
研究组 & 干预措施
Group 1
Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution.
干预措施: Methotrexate (Drug)
Group 2
Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd , 4th and 6th post operative weeks.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Development of Proliferative Vitreoretinopathy (PVR)
时间窗: Within three months of Vitrectomy surgery
Clinically evident PVR membrane formation
Recurrence of Retinal Detachment
时间窗: Within three months of Vitrectomy surgery
Re detachment of retina after retinal detachment repair surgery by vitrectomy
次要结局
- Visual Acuity Improvement(Final visual acuity will be measured at completion of 3 month follow up or meeting the primary outcome, whichever is earlier.)
研究者
Ahmad Zeeshan Jamil
Professor of Ophthalmology
University of Health Sciences Lahore