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临床试验/NCT06441656
NCT06441656已完成不适用

The (Flip and Fix) Internal Limiting Flap Technique Versus the Classic Temporal Flap for Macular Hole Repair

Alexandria University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
LogMAR visual acuity

研究概览

简要总结

Purpose To describe a novel technique of MH repair and compare it to the perfluorocarbon liquid (PFCL) assisted temporal ILM flap technique.

Methods Twenty-two eyes of 22 patients with MH were randomized on 1:1 basis into two groups. Group A cases were treated using the (Flip and Fix) technique in which the single-layer ILM flap was (flipped), flattened over the macula using PFCL and (fixed) in place using 2 drops of autologous non-heparinized blood over the superonasal and the inferonasal edges of the flap (away from the MH center). Group B patients had the classic temporal ILM flap technique without using the PFCL or autologous blood. All patients were followed up for a period of 6 months after the surgery.

Results No significant difference was observed in initial and final visual acuities between Groups A and B. Intraoperative flap displacement and did not occur in Group A and occurred in 2 eyes in Group B (18.2%) one of them showed failed MH closure and required reoperation, These 2 cases had a final (W shape) MH closure and a worse final vision than the remaining cases which had either (U shape) or (V shape) final MH closure.

Conclusions The study results show that the (Flip and Fix) technique is as effective as the PFCL-assisted temporal ILM flap technique and is associated with less ILM flap displacement risk for the repair of macular holes.

详细描述

We conducted a prospective randomized comparative interventional study in which we enrolled patients older than 50 years with idiopathic macular holes who presented to (Removed in the blinded version of manuscript) in the period between February 2021 and February 2022. Patients with previous macular surgeries and those with any other significant macular pathologies e.g., diabetic macular oedema, myopic maculopathy, choroidal neovascular membrane, or macula-off retinal detachment were excluded.

The study protocol was reviewed and approved by the Ethics Committee of (Removed in the blinded version of manuscript). All patients signed an informed consent after explaining the procedures. The study was conducted in accordance with the tenets of the Declaration of Helsinki.

For all the patients, a retina consultant (I. A.) masked to the procedure that will be done for the patient conducted a comprehensive ophthalmic examination, including best-corrected visual acuity (BCVA) (measured using the Snellen's chart and then converted to the LogMAR for the statistical analysis), slit-lamp examination, and fundus examination.

All the patients had a pre-operative macular OCT scan done. The scans were assessed by the masked retina consultant (I. A.) to confirm the diagnosis and to measure the minimum MH diameter.

The included patients were randomized by a research nurse on a 1:1 basis using the closed envelope technique to have either the new (Flip and fix) technique (Group A) or the PFCL assisted temporal inverted ILM flap technique (Group B).

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The investigator assessing the outcome was masked to the type of surgery done

入排标准

年龄范围
50 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with idiopathic macular holes who presented to (Removed in the blinded version of manuscript) in the period between February 2021 and February 2022.

排除标准

  • Patients with previous macular surgeries and those with any other significant macular pathologies e.g., diabetic macular oedema, myopic maculopathy, choroidal neovascular membrane, or macula-off retinal detachment -

结局指标

主要结局

LogMAR visual acuity

时间窗: 1, 3, and six months postoperatively

Best corrected visual acuity was assessed using the LogMAR vision

Macular hoe closure by OCT scan

时间窗: 1, 3, and six months postoperatively

Macular OCT scan was used to assess the MH closure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Shereen Hamdy

Associate Professor

Alexandria University

研究点 (1)

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