Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Not Applicable

Recruiting

• Conditions: Rhegmatogenous Retinal Detachment; Epiretinal Membrane; Vitreous Hemorrhage; Cataract; Vitreous Cloudy; Macular Disease; Vitreomacular Traction
• Interventions: Procedure: FLACS +PPV+IOL + air; Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex; Procedure: FLACS + PPV+IOL; Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + air

• Registration Number: NCT05588037
• Lead Sponsor: Aier School of Ophthalmology, Central South University

Brief Summary

Based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. To provide new solutions for the growing demand of eye health care.

Detailed Description

To evaluate the efficacy and complications of a new type of minimally invasive femtosecond laser assisted-cataract surgery (FLACS) combined with pars plana vitrectomy (PPV) with two-step anesthesia in the treatment of various common fundus diseases such as rhegmatogenous retinal detachment (RRD), epiretinal membrane (ERM), macular hole (MH), and vitreous opacity, complicated with cataract. It is mainly aimed at the following kinds of common fundus diseases with cataract performing PPV and cataract removal combined with monofocal or premium intraocular lens (IOL) implantation： RRD complicated with cataract: FLACS +PPV + IOL+air; ERM complicated with cataract: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex; MH complicated with cataract: FLACS + PPV+ IOL + internal limiting membrane peeling + air; Vitreous opacity with cataract: FLACS + PPV+ IOL.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2020-12-08
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

clinical diagnosis of following disease

• RRD with cataract
• ERM with cataract
• MH with cataract
• Vitreous opacity with cataract

Exclusion Criteria

patients with history of following condition

• intraocular surgery
• ocular trauma
• endophthalmitis
• uveitis
• glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RRD group	FLACS +PPV+IOL + air	to evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of rhegmatogenous retinal detachment complicated with cataract.
ERM group	FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex	to evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of epiretinal membrane complicated with cataract.
Vitreous cloudy group	FLACS + PPV+IOL	to evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of vitreous opacity complicated with cataract.
MH group	FLACS + PPV+IOL + internal limiting membrane peeling + air	to evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of macular hole complicated with cataract.

Primary Outcome Measures

Name	Time	Method
visual acuity	Change from baseline best-corrected visual acuity at 6 months.	final best-corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
complications	through study completion, an average of 6 months.	complications occurred during surgery or post-surgery

Trial Locations

Locations (1)

Jiasong Yang; 🇨🇳 Shanghai, China