Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

October 17, 2022 updated by: Aier School of Ophthalmology, Central South University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jiasong Yang
  • Phone Number: +8619916531690
  • Email: cammel@qq.com

Study Contact Backup

  • Name: Wensheng Li
  • Phone Number: +8613761975020
  • Email: drlws@qq.com

Study Locations

  • China
      • Shanghai, China, 200000
        • Recruiting
        • Jiasong Yang
        • Contact:
          • Jiasong Yang
          • Phone Number: +8618650424985 18113024536
          • Email: cammel@qq.com
        • Sub-Investigator:
          • Jiasong Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: Change from baseline best-corrected visual acuity at 6 months.
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
Time Frame: through study completion, an average of 6 months.
complications occurred during surgery or post-surgery
through study completion, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aier School of Ophthalmology, Central South University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIRB2018019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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