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Status unknownNCT05588037Updated Oct 20, 2022

Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

An interventional study of FLACS +PPV+IOL + air and FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex in Macular Disease, Rhegmatogenous Retinal Detachment and Epiretinal Membrane, sponsored by Aier School of Ophthalmology, Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by Aier School of Ophthalmology, Central South University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Macular Disease
  • Rhegmatogenous Retinal Detachment
  • Epiretinal Membrane
  • Cataract
  • Vitreous Hemorrhage
  • Vitreomacular Traction
  • Vitreous Cloudy
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's planned enrollment of 100 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Aier School of Ophthalmology, Central South University is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • ProcedureFLACS +PPV+IOL + air

    The procedures are combined the FLACS +PPV+IOL + air.

  • ProcedureFLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex

    The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.

  • ProcedureFLACS + PPV+IOL + internal limiting membrane peeling + air

    The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.

  • ProcedureFLACS + PPV+IOL

    The procedures are combined the FLACS + PPV+IOL.

06

What researchers measure

Primary outcomes

  1. visual acuity

    final best-corrected visual acuity

    Time frame: Change from baseline best-corrected visual acuity at 6 months.

Secondary outcomes

  1. complications

    complications occurred during surgery or post-surgery

    Time frame: through study completion, an average of 6 months.

07

Study locations

1 of 1 sites recruiting
  • Jiasong Yang
    Shanghai, 200000, China
    Recruiting
    • Jiasong Yang · Contactcammel@qq.com · 18113024536
    • Wensheng Li · Contactdrlws@qq.com · +8618650424985
    • Wensheng Li · Principal investigator
    • Jiasong Yang · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for Dec 2023, 83 months after the start.

Of 104 non-industry interventional studies with no phase under Macular Degeneration, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 83 months is above that.

Counting every sponsor, half of 132 studies reached it within 37 months; a quarter within 17 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2020
First posted
Oct 20, 2022
StartActual
Jan 1, 2017
Primary completionEst.
Dec 31, 2023
CompletionEst.
Dec 31, 2023
Last update
Oct 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05588037
Lead sponsor
Aier School of Ophthalmology, Central South University
Responsible party
Sponsor
First posted
Oct 20, 2022
Start date
Jan 1, 2017
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 20, 2022

Study contacts

Jiasong Yang
Contact
cammel@qq.com
+8619916531690
Wensheng Li
Contact
drlws@qq.com
+8613761975020
Wensheng Li
study chair · Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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