Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

NCT ID: NCT05588037

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RRD group

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.

Group Type EXPERIMENTAL

FLACS +PPV+IOL + air

Intervention Type PROCEDURE

The procedures are combined the FLACS +PPV+IOL + air.

ERM group

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.

Group Type EXPERIMENTAL

FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex

Intervention Type PROCEDURE

The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.

MH group

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.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.

Vitreous cloudy group

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.

Group Type EXPERIMENTAL

FLACS + PPV+IOL

Intervention Type PROCEDURE

The procedures are combined the FLACS + PPV+IOL.

Interventions

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FLACS +PPV+IOL + air

The procedures are combined the FLACS +PPV+IOL + air.

Intervention Type PROCEDURE

FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex

The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.

Intervention Type PROCEDURE

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

The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.

Intervention Type PROCEDURE

FLACS + PPV+IOL

The procedures are combined the FLACS + PPV+IOL.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* RRD with cataract
* ERM with cataract
* MH with cataract
* Vitreous opacity with cataract

Exclusion Criteria

* intraocular surgery
* ocular trauma
* endophthalmitis
* uveitis
* glaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aier School of Ophthalmology, Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wensheng Li

Role: STUDY_CHAIR

Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital

Locations

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Jiasong Yang

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiasong Yang

Role: CONTACT

+8619916531690

Wensheng Li

Role: CONTACT

+8613761975020

Facility Contacts

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Jiasong Yang

Role: primary

18113024536 ext. +8618650424985

Wensheng Li

Role: backup

+8618650424985 ext. +8618650424985

Other Identifiers

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SHIRB2018019

Identifier Type: -

Identifier Source: org_study_id

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