Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Cataract Clinical Trial

Official title:

Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588037
• Other study ID #: SHIRB2018019
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Aier School of Ophthalmology, Central South University
• Contact: Jiasong Yang
• Phone: +8619916531690
• Email: cammel[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• FLACS +PPV+IOL + air
The procedures are combined the FLACS +PPV+IOL + air.
• FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex
The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.
• FLACS + PPV+IOL + internal limiting membrane peeling + air
The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.
• FLACS + PPV+IOL
The procedures are combined the FLACS + PPV+IOL.

Locations

Country	Name	City	State
China	Jiasong Yang	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	final best-corrected visual acuity	Change from baseline best-corrected visual acuity at 6 months.
Secondary	complications	complications occurred during surgery or post-surgery	through study completion, an average of 6 months.