Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Aier School of Ophthalmology, Central South University

Status: Enrolling

Conditions: Vitreomacular Traction; Cataract; Vitreous Cloudy; Macular Disease; Vitreous Hemorrhage; Epiretinal Membrane; Rhegmatogenous Retinal Detachment

Treatments: Procedure: FLACS + PPV+IOL; Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + air; Procedure: FLACS +PPV+IOL + air; Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex

Study type: Interventional

Funder types: Other

Identifiers

NCT05588037

SHIRB2018019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

RRD group

Experimental group

Description:

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.

Treatment:

Procedure: FLACS +PPV+IOL + air

ERM group

Experimental group

Description:

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.

Treatment:

Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex

MH group

Experimental group

Description:

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.

Treatment:

Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + air

Vitreous cloudy group

Experimental group

Description:

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.

Treatment:

Procedure: FLACS + PPV+IOL