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临床试验/NCT06826573
NCT06826573招募中不适用

Analysis of Risk Factors for High Intraocular Pressure and Retinal Detachment Recurrence After Vitrectomy with Silicone Oil Tamponade in Retinal Detachment Patients

First Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
65
试验地点
1
主要终点
Intraocular pressure

研究概览

简要总结

This study is a retrospective study. Patients who visited the ophthalmology clinic of the First Affiliated Hospital of Chongqing Medical University between September 1, 2024, and December 31, 2025, will be screened according to the inclusion and exclusion criteria mentioned below. After obtaining informed consent, clinical data of the subjects will be collected. The surgical procedure will involve "vitrectomy + retinal laser photocoagulation + retinal reattachment + silicone oil tamponade (+ cataract extraction + intraocular lens implantation)." Observation indicators will be recorded at various time points postoperatively: 1 day, 1 week, 1 month, 3 months, 6 months, and before silicone oil removal. Any emergent events occurring during the trial will be treated accordingly. Finally, data will be statistically analyzed to identify risk factors for high intraocular pressure and retinal detachment recurrence in patients with rhegmatogenous retinal detachment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with "rhegmatogenous retinal detachment".
  • •Aged over 18 years old, with normal mental and psychological status, regardless of gender.
  • •Intraocular pressure of both eyes is less than 21 mmHg before surgery, and having no personal or family history of glaucoma.
  • •Cup - to - disc ratio (C/D) in fundus examination is less than 0.5 for both eyes.
  • •Those who understand the purpose of this study, sign the "Informed Consent Form" and have a high degree of compliance.

排除标准

  • •Those with high intraocular pressure before surgery and suffering from ophthalmic diseases such as glaucoma;
  • •Those with acute or chronic systemic infections and hematological diseases;
  • •Those with a history of mental and psychological diseases;
  • •Those with incomplete survey data or unable to cooperate with this research.
  • •Those with traumatic rhegmatogenous retinal detachment;
  • •Those with active ocular infectious lesions in either eye;
  • •Those with severe refractive media opacity (such as corneal nebula, corneal leukoma) in the target eye, which affects imaging examinations during postoperative follow - up.
  • •Those with a history of congenital structural abnormalities in the target eye;
  • •Those who have undergone vitrectomy for other vitreoretinal diseases in the target eye before screening;
  • •Those whom the researchers consider unfit to participate in this clinical trial.

结局指标

主要结局

Intraocular pressure

时间窗: The study will be conducted from September 1, 2024, to December 31, 2025. Key follow-up time points include 1 day, 1 week, 1 month, 3 months, 6 months postoperatively, and before silicone oil removal

If the intraocular pressure is greater than 21 mmHg at any time during the follow - up period, it is considered as an increase in intraocular pressure.

the retinal recovery status

时间窗: The study will be conducted from September 1, 2024, to December 31, 2025. Key follow-up time points include 1 day, 1 week, 1 month, 3 months, 6 months postoperatively, and before silicone oil removal.

Measure and record the retinal status 1 day, 1 week, 1 month, 3 months, 6 months after surgery and before silicone - oil removal. If retinal detachment occurs again, it is regarded as the recurrence of retinal detachment.

次要结局

未报告次要终点

研究者

发起方
First Affiliated Hospital of Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Peng

PH.D

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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