RetinoschisisNCT03023800
Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes
A study testing Macular buckling and Vitrectomy in people with Retinoschisis and Macular Detachment, run by Sun Yat-sen University at 1 site in China.
Trial summary
Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinoschisis, Macular Detachment, High Myopia
- What is being tested?
- Macular buckling and Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to 12 Oct 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- macular schisis
- macular retinal detachment
- evidence of posterior staphyloma on clinical examination
Who cannot join
- severe macular scar
- macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- prominent vitreomacular traction
- a history of vitrectomy or macular buckle
- intraocular active hemorrhage or inflammation
- any media opacity which precluded imaging or clinical evaluation of the macula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia
Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.
Read the detailed description
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.
- Conditions
- Retinoschisis, Macular Detachment, High Myopia
- Being tested
- Macular buckling, Vitrectomy
- Medical subject headings
- Retinoschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macular bucklingProcedure or surgery
Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.
VitrectomyProcedure or surgery
Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Buckle | Experimental | Macular buckling and intraocular gas (C3F8) injection. Receives: Procedure: Macular buckling |
| Vitrectomy | Active comparator | Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8). Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal re-attachment rate
Measured: 3 month
Secondary outcomes (2)
Post-operative best corrected visual acuity
Measured: 12 month
Post-operative macular structure on optical coherance tomography
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startApr 2015
- Primary completion30 Jan 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoschisisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lu, Sun Yat-sen University
- Investigators
- Lin Lu, MD，PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023800
- Sponsor's protocol ID
- 2013meky013(2)
- Status last verified
- Oct 2017
- First submitted
- 16 Jan 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia
- ClinicalTrials.gov ID
- NCT03023800
- Acronym / sponsor ID
- 2013meky013(2)
- Conditions
- Retinoschisis, Macular Detachment, High Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.
Detailed description
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buckle | Experimental | Procedure: Macular bucklingMacular buckling and intraocular gas (C3F8) injection. |
| Vitrectomy | Active comparator | Procedure: VitrectomyVitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- macular schisis
- macular retinal detachment
- evidence of posterior staphyloma on clinical examination
Key exclusion criteria (6 listed)
- severe macular scar
- macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- prominent vitreomacular traction
- a history of vitrectomy or macular buckle
- intraocular active hemorrhage or inflammation
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 |
|---|---|---|
| Macular bucklingSurgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia. | Procedure or surgery | Buckle |
| VitrectomySurgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia | Procedure or surgery | Vitrectomy |
Primary outcome
Retinal re-attachment rate
Time frame: 3 month
2 secondary outcomes
Post-operative best corrected visual acuity
Time frame: 12 month
Post-operative macular structure on optical coherance tomography
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Lin Lu, MD，PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macular buckling and Vitrectomy in people with Retinoschisis and Macular Detachment, run by Sun Yat-sen 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 4 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: finished, as of the sponsor's last update on 16 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal re-attachment rate (time frame: 3 month). 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 16 Oct 2017.