Macular DiseaseNCT05588037
Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
A study testing FLACS +PPV+IOL + air, FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex and FLACS + PPV+IOL + internal limiting membrane peeling + air in people with Macular Disease and Rhegmatogenous Retinal Detachment, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Disease, Rhegmatogenous Retinal Detachment, Epiretinal Membrane
- What is being tested?
- FLACS +PPV+IOL + air, FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex and FLACS + PPV+IOL + internal limiting membrane peeling + air
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RRD with cataract
- ERM with cataract
- MH with cataract
- Vitreous opacity with cataract
- Exclusion Criteria: patients with history of following condition
- intraocular surgery
Show all 10Show fewer
- ocular trauma
- endophthalmitis
- uveitis
- glaucoma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiasong Yang
Shanghai, 200000
Jiasong Yang, 18113024536 ext. +8618650424985, cammel@qq.com
Wensheng Li, +8618650424985 ext. +8618650424985, drlws@qq.com
About this study
Official title: 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.
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.
- Conditions
- Macular Disease, Rhegmatogenous Retinal Detachment, Epiretinal Membrane, Cataract, Vitreous Hemorrhage, Vitreomacular Traction
- Being tested
- FLACS +PPV+IOL + air, FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex, FLACS + PPV+IOL + internal limiting membrane peeling + air, FLACS + PPV+IOL
- Medical subject headings
- Macular Degeneration, Epiretinal Membrane, Cataract, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLACS +PPV+IOL + airProcedure or surgery
The procedures are combined the FLACS +PPV+IOL + air.
FLACS +PPV+IOL + epiretinal membrane peeling + OzurdexProcedure or surgery
The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.
FLACS + PPV+IOL + internal limiting membrane peeling + airProcedure or surgery
The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.
FLACS + PPV+IOLProcedure or surgery
The procedures are combined the FLACS + PPV+IOL.
| Study group | Role | What they receive |
|---|---|---|
| RRD group | Experimental | 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. Receives: Procedure: FLACS +PPV+IOL + air |
| ERM group | Experimental | 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. Receives: Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex |
| MH group | Experimental | 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. Receives: Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + air |
| Vitreous cloudy group | Experimental | 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. Receives: Procedure: FLACS + PPV+IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
final best-corrected visual acuity
Measured: Change from baseline best-corrected visual acuity at 6 months.
Secondary outcomes (1)
complications
complications occurred during surgery or post-surgery
Measured: through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wensheng Li, Study chair, Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588037
- Sponsor's protocol ID
- SHIRB2018019
- Status last verified
- Oct 2022
- First submitted
- 8 Dec 2020
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT05588037
- Acronym / sponsor ID
- SHIRB2018019
- Conditions
- Macular Disease, Rhegmatogenous Retinal Detachment, Epiretinal Membrane, Cataract, Vitreous Hemorrhage, Vitreomacular Traction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RRD group | Experimental | Procedure: FLACS +PPV+IOL + airto 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. |
| ERM group | Experimental | Procedure: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdexto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of epiretinal membrane complicated with cataract. |
| MH group | Experimental | Procedure: FLACS + PPV+IOL + internal limiting membrane peeling + airto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of macular hole complicated with cataract. |
| Vitreous cloudy group | Experimental | Procedure: FLACS + PPV+IOLto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of vitreous opacity complicated with cataract. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- RRD with cataract
- ERM with cataract
- MH with cataract
- Vitreous opacity with cataract
- Exclusion Criteria: patients with history of following condition
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLACS +PPV+IOL + airThe procedures are combined the FLACS +PPV+IOL + air. | Procedure or surgery | RRD group |
| FLACS +PPV+IOL + epiretinal membrane peeling + OzurdexThe procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex. | Procedure or surgery | ERM group |
| FLACS + PPV+IOL + internal limiting membrane peeling + airThe procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air. | Procedure or surgery | MH group |
| FLACS + PPV+IOLThe procedures are combined the FLACS + PPV+IOL. | Procedure or surgery | Vitreous cloudy group |
Primary outcome
visual acuity
Time frame: Change from baseline best-corrected visual acuity at 6 months.
final best-corrected visual acuity
1 secondary outcome
complications
Time frame: through study completion, an average of 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wensheng Li study chair
Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLACS +PPV+IOL + air, FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex and FLACS + PPV+IOL + internal limiting membrane peeling + air in people with Macular Disease and Rhegmatogenous Retinal Detachment, run by Aier School of Ophthalmology, Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiasong Yang (+8619916531690, cammel@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: Change from baseline best-corrected visual acuity at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.