Retinal DiseaseNCT03586193
Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes
An observational study of Retinal Disease and Macular Retinoschisis, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial summary
High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Disease, Macular Retinoschisis
- What is being tested?
- Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 May 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.
Who may be able to join
- Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
- Morphologic manifestation in OCT shows split between retinal layers in macular area.
- Patients without severe systemic disease and can tolerate surgery.
Who cannot join
- Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
- Patients with nystagmus or have difficult to open the eye.
- Patients with severe systemic disease and cannot tolerate surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Aier Eye hospital
Shanghai, 200000
Zhuyun Qian, Doctor, +8613817109809 ext. +8618650424985, qianzhuyun552@126.com
Wensheng Li, Doctor, +8618650424985 ext. +8618650424985, drlws@qq.com
About this study
Official title: Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes
High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.
- Conditions
- Retinal Disease, Macular Retinoschisis
- Being tested
- Pars plana vitrectomy
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
pars plana vitrectomy without ICG staining and ILM peeling
| Study group | Role | What they receive |
|---|---|---|
| patients with HMF | Patients who are diagnosed as high myopic macular schisis and agree to receive pars plana vitrectomy as the treatment are planned to allocated in this group Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The morphologic change of macular area
The thickness of the macular fovea in optical coherence tomography (OCT)
Measured: OCT will be done one day before surgery and one week, one month, three months and six months after surgery
Secondary outcomes (3)
The best corrected visual acuity (BCVA) change
The BCVA of all involved patients
Measured: One day before surgery and one week, one month, three months and six months after surgery
The best corrected near visual acuity (BCNVA) change
The BCNVA of all involved patients
Measured: One day before surgery and one week, one month, three months and six months after surgery
The visual function change
The contrast sensitivity of all involved patients
Measured: One day before surgery and one week, one month, three months and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 May 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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, Doctor, Study director, Shanghai Aier Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586193
- Sponsor's protocol ID
- SHIRB2018014
- Status last verified
- Jul 2018
- First submitted
- 15 Jun 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results
Publications
Chang JS, Flynn HW Jr, Engelbert M, Shane AR, Smiddy WE, Chang S. Pars plana vitrectomy in patients with myopic macular retinoschisis. Br J Ophthalmol. 2014 Apr;98(4):534-7. doi: 10.1136/bjophthalmol-2013-304578. Epub 2014 Jan 10.
PubMed 24414402Zhang Z, Wei Y, Jiang X, Zhang S. PARS PLANA VITRECTOMY AND WIDE INTERNAL LIMITING MEMBRANE PEELING WITH PERFLUOROPROPANE TAMPONADE FOR HIGHLY MYOPIC FOVEOSCHISIS-ASSOCIATED MACULAR HOLE. Retina. 2017 Feb;37(2):274-282. doi: 10.1097/IAE.0000000000001146.
PubMed 27429390Rey A, Jurgens I, Maseras X, Carbajal M. Natural course and surgical management of high myopic foveoschisis. Ophthalmologica. 2014;231(1):45-50. doi: 10.1159/000355324. Epub 2013 Nov 12.
PubMed 24246446
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Pars Plana Vitrectomy in the Treatment of Macular Schisis in High Myopic Eyes
- ClinicalTrials.gov ID
- NCT03586193
- Acronym / sponsor ID
- SHIRB2018014
- Conditions
- Retinal Disease, Macular Retinoschisis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 13 Jul 2018 (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.
High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with HMF | – | Procedure: Pars plana vitrectomyPatients who are diagnosed as high myopic macular schisis and agree to receive pars plana vitrectomy as the treatment are planned to allocated in this group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will be selected from the in-patients in Shanghai Aier Eye Hospital.
Key inclusion criteria (3 listed)
- Patients diagnosed as high myopic macular retinoschisis, with axial length more than 26.5mm.
- Morphologic manifestation in OCT shows split between retinal layers in macular area.
- Patients without severe systemic disease and can tolerate surgery.
Key exclusion criteria (3 listed)
- Patients also have other ocular disease, including glaucoma, keratitis,uveitis, retinal detachment,etc.
- Patients with nystagmus or have difficult to open the eye.
- Patients with severe systemic disease and cannot tolerate surgery.
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 |
|---|---|---|
| Pars plana vitrectomypars plana vitrectomy without ICG staining and ILM peeling | Procedure or surgery | patients with HMF |
Primary outcome
The morphologic change of macular area
Time frame: OCT will be done one day before surgery and one week, one month, three months and six months after surgery
The thickness of the macular fovea in optical coherence tomography (OCT)
3 secondary outcomes
The best corrected visual acuity (BCVA) change
Time frame: One day before surgery and one week, one month, three months and six months after surgery
The best corrected near visual acuity (BCNVA) change
Time frame: One day before surgery and one week, one month, three months and six months after surgery
The visual function change
Time frame: One day before surgery and one week, one month, three months and six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Background: PubMed 24414402Chang JS, Flynn HW Jr, Engelbert M, Shane AR, Smiddy WE, Chang S. Pars plana vitrectomy in patients with myopic macular retinoschisis. Br J Ophthalmol. 2014 Apr;98(4):534-7. doi: 10.1136/bjophthalmol-2013-304578. Epub 2014 Jan 10.
- Results publication: PubMed 27429390Zhang Z, Wei Y, Jiang X, Zhang S. PARS PLANA VITRECTOMY AND WIDE INTERNAL LIMITING MEMBRANE PEELING WITH PERFLUOROPROPANE TAMPONADE FOR HIGHLY MYOPIC FOVEOSCHISIS-ASSOCIATED MACULAR HOLE. Retina. 2017 Feb;37(2):274-282. doi: 10.1097/IAE.0000000000001146.
- Results publication: PubMed 24246446Rey A, Jurgens I, Maseras X, Carbajal M. Natural course and surgical management of high myopic foveoschisis. Ophthalmologica. 2014;231(1):45-50. doi: 10.1159/000355324. Epub 2013 Nov 12.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results
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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, Doctor study director
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?
An observational study of Retinal Disease and Macular Retinoschisis, 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 3 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 13 Jul 2018. 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 Zhuyun Qian, Doctor (+8613817109809 ext. +8618650424985, qianzhuyun552@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The morphologic change of macular area (time frame: OCT will be done one day before surgery and one week, one month, three months and six months after surgery). 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 NCT03586193, which also lists 3 linked publications.
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 13 Jul 2018.