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Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Primary Purpose

Macular Disease, Rhegmatogenous Retinal Detachment, Epiretinal Membrane

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FLACS +PPV+IOL + air
FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex
FLACS + PPV+IOL + internal limiting membrane peeling + air
FLACS + PPV+IOL
Sponsored by
Aier School of Ophthalmology, Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jiasong YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

RRD group

ERM group

MH group

Vitreous cloudy group

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

visual acuity
final best-corrected visual acuity

Secondary Outcome Measures

complications
complications occurred during surgery or post-surgery

Full Information

First Posted
December 8, 2020
Last Updated
October 17, 2022
Sponsor
Aier School of Ophthalmology, Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05588037
Brief Title
Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
Official Title
Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aier School of Ophthalmology, Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Disease, Rhegmatogenous Retinal Detachment, Epiretinal Membrane, Cataract, Vitreous Hemorrhage, Vitreomacular Traction, Vitreous Cloudy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RRD group
Arm Type
Experimental
Arm 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.
Arm Title
ERM group
Arm Type
Experimental
Arm 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.
Arm Title
MH group
Arm Type
Experimental
Arm 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.
Arm Title
Vitreous cloudy group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
FLACS +PPV+IOL + air
Intervention Description
The procedures are combined the FLACS +PPV+IOL + air.
Intervention Type
Procedure
Intervention Name(s)
FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex
Intervention Description
The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.
Intervention Type
Procedure
Intervention Name(s)
FLACS + PPV+IOL + internal limiting membrane peeling + air
Intervention Description
The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.
Intervention Type
Procedure
Intervention Name(s)
FLACS + PPV+IOL
Intervention Description
The procedures are combined the FLACS + PPV+IOL.
Primary Outcome Measure Information:
Title
visual acuity
Description
final best-corrected visual acuity
Time Frame
Change from baseline best-corrected visual acuity at 6 months.
Secondary Outcome Measure Information:
Title
complications
Description
complications occurred during surgery or post-surgery
Time Frame
through study completion, an average of 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiasong Yang
Phone
+8619916531690
Email
cammel@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wensheng Li
Phone
+8613761975020
Email
drlws@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wensheng Li
Organizational Affiliation
Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jiasong Yang
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiasong Yang
Phone
18113024536
Ext
+8618650424985
Email
cammel@qq.com
First Name & Middle Initial & Last Name & Degree
Wensheng Li
Phone
+8618650424985
Ext
+8618650424985
Email
drlws@qq.com
First Name & Middle Initial & Last Name & Degree
Wensheng Li
First Name & Middle Initial & Last Name & Degree
Jiasong Yang

12. IPD Sharing Statement

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Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

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