Macular SchisisRecoveryNCT04146350

A Prospective Multicenter Study of Different Surgical Methods in the Treatment of High Myopic Macular Schisis

A study testing PPV+/-Cat, PPV+/-Cat+Gas and PPV+ILM+/-Cat+/-Gas in people with Macular Schisis, run by Aier School of Ophthalmology, Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

In view of the current problem of treating high myopic macular schisis, the main purpose of our study is to find out the most appropriate time of surgical intervention, to compare the effectiveness and safety of various surgical methods in the treatment of high myopic macular schisis, and to find out the advantages… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Macular Schisis
What is being tested?: PPV+/-Cat, PPV+/-Cat+Gas and PPV+ILM+/-Cat+/-Gas
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteChina
Study dates: 7 Oct 2019to 7 Jun 2022
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

diopter ≤-6.00D or axial length ≥ 26.00mm;
OCT showed macular schisis with or without macular retinal detachment;
agreed to participate in this project and signed informed consent form.

Who cannot join

OCT confirmed full-thickness macular hole with or without macular retinal detachment；
submacular active or inactive CNV;
previous vitreoretinal surgery and anti-glaucoma surgery；
with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;
complicated with severe systemic disease can not tolerate surgery or follow-up;
do not agree to participate the project or disagree with the follow-up.

Trial locations and contacts

1 site in 1 country.

Jiasong Yang contact

Wensheng Li contact

China1 site, 1 recruiting

Shanghai Aier Eye Hospital
Shanghai, Shanghai Municipality, 200000
Jiasong Yang, +8618113024536, cammel@qq.com
Wensheng Li, +8618650424985, drlws@qq.com
Recruiting

Other trials in China

About this study

Official title: A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World

Conditions: Macular Schisis
Being tested: PPV+/-Cat, PPV+/-Cat+Gas, PPV+ILM+/-Cat+/-Gas, PPV+ILM+/-Cat+/-Oil, PSR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PPV+/-CatProcedure or surgery
pars plana vitrectomy+/-cataract
PPV+/-Cat+GasProcedure or surgery
pars plana vitrectomy+/-cataract+gas tamponade
PPV+ILM+/-Cat+/-GasProcedure or surgery
pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade
PPV+ILM+/-Cat+/-OilProcedure or surgery
pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade
PSRProcedure or surgery
posterior scleral reinforcement
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）Procedure or surgery
posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)
GasProcedure or surgery
gas tamponade alone

Study groups in NCT04146350
Study group	Role	What they receive
Control	No intervention	Not described
PPV+/-Cat	Active comparator	Not described Receives: Procedure: PPV+/-Cat
PPV+/-Cat+Gas	Active comparator	Not described Receives: Procedure: PPV+/-Cat+Gas
PPV+ILM+/-Cat+/-Gas	Active comparator	Not described Receives: Procedure: PPV+ILM+/-Cat+/-Gas
PPV+ILM+/-Cat+/-Oil	Active comparator	Not described Receives: Procedure: PPV+ILM+/-Cat+/-Oil
PSR	Active comparator	Not described Receives: Procedure: PSR
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）	Active comparator	Not described Receives: Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
Gas	Active comparator	Not described Receives: Procedure: Gas

What is being measured

The primary outcome is the main question the study is designed to answer.

foveal thickness
measured by OCT
Measured: change from baseline foveal thickness at 3, 6, 9, 12 months
retinal thickness of the most significant schisis
measured by OCT
Measured: change from baseline at 3, 6, 9, 12 months

Secondary outcomes (4)

best corrected visual acuity
BCVA
Measured: change from baseline at 3, 6, 9, 12 months
mf-ERG
multifocal-ERG
Measured: change from baseline at 3, 6, 9, 12 months
Visual quality questionnaire
Visual quality questionnaire
Measured: change from baseline at 3, 6, 9, 12 months
axial length
axial length measured by IOL Master
Measured: change from baseline at 3, 6, 9, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 20197 Jun 2022

First posted31 Oct 2019
Study start7 Oct 2019
Primary completion7 Oct 2021 (estimated)
Study completion7 Jun 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Macular SchisisStudies 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: Factorial
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04146350
Sponsor's protocol ID: AM1901D3
Acronym: Recovery
Status last verified: Oct 2019
First submitted: 24 Oct 2019
Last updated: 31 Oct 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Dolar-Szczasny J, Swiech-Zubilewicz A, Mackiewicz J. A Review of Current Myopic Foveoschisis Management Strategies. Semin Ophthalmol. 2019;34(3):146-156. doi: 10.1080/08820538.2019.1610180. Epub 2019 May 6.
PubMed 31060414

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Study of Different Surgical Methods for the Treatment of Macular Schisis in High Myopia Based on the Real World
ClinicalTrials.gov ID: NCT04146350
Acronym / sponsor ID: Recovery / AM1901D3
Conditions: Macular Schisis
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
Study start: 7 Oct 2019 (actual)
Primary completion: 7 Oct 2021 (estimated)
Study completion: 7 Jun 2022 (estimated)
First posted: 31 Oct 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Control	No intervention	–
PPV+/-Cat	Active comparator	Procedure: PPV+/-Cat
PPV+/-Cat+Gas	Active comparator	Procedure: PPV+/-Cat+Gas
PPV+ILM+/-Cat+/-Gas	Active comparator	Procedure: PPV+ILM+/-Cat+/-Gas
PPV+ILM+/-Cat+/-Oil	Active comparator	Procedure: PPV+ILM+/-Cat+/-Oil
PSR	Active comparator	Procedure: PSR
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）	Active comparator	Procedure: PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
Gas	Active comparator	Procedure: Gas

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

diopter ≤-6.00D or axial length ≥ 26.00mm;
OCT showed macular schisis with or without macular retinal detachment;
agreed to participate in this project and signed informed consent form.

Key exclusion criteria (6 listed)

OCT confirmed full-thickness macular hole with or without macular retinal detachment；
submacular active or inactive CNV;
previous vitreoretinal surgery and anti-glaucoma surgery；
with rhegmatogenous retinal detachment, ocular trauma, glaucoma, corneal opacity and other ophthalmic diseases;
complicated with severe systemic disease can not tolerate surgery or follow-up;

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
PPV+/-Catpars plana vitrectomy+/-cataract	Procedure or surgery	PPV+/-Cat
PPV+/-Cat+Gaspars plana vitrectomy+/-cataract+gas tamponade	Procedure or surgery	PPV+/-Cat+Gas
PPV+ILM+/-Cat+/-Gaspars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade	Procedure or surgery	PPV+ILM+/-Cat+/-Gas
PPV+ILM+/-Cat+/-Oilpars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade	Procedure or surgery	PPV+ILM+/-Cat+/-Oil
PSRposterior scleral reinforcement	Procedure or surgery	PSR
PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)	Procedure or surgery	PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）
Gasgas tamponade alone	Procedure or surgery	Gas

Primary outcome

foveal thickness
Time frame: change from baseline foveal thickness at 3, 6, 9, 12 months
measured by OCT
retinal thickness of the most significant schisis
Time frame: change from baseline at 3, 6, 9, 12 months
measured by OCT

4 secondary outcomes

best corrected visual acuity
Time frame: change from baseline at 3, 6, 9, 12 months
mf-ERG
Time frame: change from baseline at 3, 6, 9, 12 months
Visual quality questionnaire
Time frame: change from baseline at 3, 6, 9, 12 months
axial length
Time frame: change from baseline at 3, 6, 9, 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
Background: PubMed 31060414Dolar-Szczasny J, Swiech-Zubilewicz A, Mackiewicz J. A Review of Current Myopic Foveoschisis Management Strategies. Semin Ophthalmol. 2019;34(3):146-156. doi: 10.1080/08820538.2019.1610180. Epub 2019 May 6.
Individual participant dataSharing planned: No

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.

Jiasong Yang contact

Wensheng Li contact

Weisheng Li study chair

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 PPV+/-Cat, PPV+/-Cat+Gas and PPV+ILM+/-Cat+/-Gas in people with Macular Schisis, 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 3 inclusion and 6 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 31 Oct 2019. 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 (+8618113024536, cammel@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

foveal thickness (time frame: change from baseline foveal thickness at 3, 6, 9, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04146350, which also lists 1 linked publication.

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 31 Oct 2019.