Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Study Overview
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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.

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

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RRD group<br>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<br>* The procedures are combined the FLACS +PPV+IOL + air.<br>|
| Experimental: ERM group<br>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<br>* The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.<br>|
| Experimental: MH group<br>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<br>* The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.<br>|
| Experimental: Vitreous cloudy group<br>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<br>* The procedures are combined the FLACS + PPV+IOL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | final best-corrected visual acuity | Change from baseline best-corrected visual acuity at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | complications occurred during surgery or post-surgery | through study completion, an average of 6 months. |