Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

• Sponsor: Aier School of Ophthalmology, Central South University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05588037
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 83.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Disease; Rhegmatogenous Retinal Detachment; Epiretinal Membrane; Cataract; Vitreous Hemorrhage; Vitreomacular Traction; Vitreous Cloudy	Procedure: FLACS +PPV+IOL + air; Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex; Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + air; Procedure: FLACS + PPV+IOL	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
• Actual Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: FLACS +PPV+IOL + air; The procedures are combined the FLACS +PPV+IOL + air.
Experimental: 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.	Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex; The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.
Experimental: 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.	Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + air; The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.
Experimental: 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.	Procedure: FLACS + PPV+IOL; The procedures are combined the FLACS + PPV+IOL.

Outcome Measures

Primary Outcome Measures

1. visual acuity [Change from baseline best-corrected visual acuity at 6 months.]

   final best-corrected visual acuity

Secondary Outcome Measures

1. complications [through study completion, an average of 6 months.]

   complications occurred during surgery or post-surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiasong Yang	Shanghai		China	200000

Sponsors and Collaborators

• Aier School of Ophthalmology, Central South University

Investigators

• Study Chair: Wensheng Li, Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aier School of Ophthalmology, Central South University
• ClinicalTrials.gov Identifier: NCT05588037
• Other Study ID Numbers: SHIRB2018019
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Retinal Detachment; Epiretinal Membrane; Vitreous Hemorrhage; Hemorrhage; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

No Results Posted as of Oct 20, 2022