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High MyopiaMBTASNCT02169635

Macular Buckle With Three-armed Silicone

A study testing macular buckle in people with High Myopia and Posterior Staphyloma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High myopia is characterized by prolonged axial length and posterior staphyloma, which result in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to anatomical improvements, but an higher axial length and the presence of a sever posterior staphyloma remains to be the two most important… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
High Myopia, Posterior Staphyloma
What is being tested?
macular buckle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteChina
Study dates
May 2013to Jun 2014
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • high myopia over -8.0 Diopter
  • axial length over 26.5 mm
  • posterior staphyloma

Who cannot join

  • single eye patients
  • retinal detachment beyond macular area
  • a history of posterior scleritis
  • a history of Glaucoma
  • active hemorrhage in the surgical eye
  • active inflammation in the surgical eye
  • any situation that might hinder the observation of macular

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Safety and Efficacy Study of Macular Buckle With A Three-armed Silicone Capsule to Support the Posterior Staphyloma in High Myopia.

High myopia is characterized by prolonged axial length and posterior staphyloma, which result in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to anatomical improvements, but an higher axial length and the presence of a sever posterior staphyloma remains to be the two most important risk factors for poor visual outcomes. For these reasons, a different surgical approach, including macular buckling, might be considered in those patients with extremely high degree of myopia, in order to counteract the traction exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy had been proved to be an effective way to resolve myopic staphyloma related foveoschisis, macular hole, and associated retinal detachment. In this study, we sought to investigate the safety and efficacy of a macular buckling technique using a three-armed silicone capsule to support the posterior staphyloma in high myopia.

Read the detailed description
  1. This study plans to recruit 11 participants with 6 months follow-up to assess the safety and efficacy of a newly designed macular buckle device;
  2. The macular buckle device, surgical procedure, and participants registry had been reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;
  3. Only those patients are diagnosed with severe posterior staphyloma are registered.
  4. All participants are fully informed before register;
  5. All the surgeries are performed by single qualified doctor (Lin Lu);
  6. After operation, all participant could contact the researcher via telephone, and could be assessed for any surgical related complications. If there is severe complication happened, or any person that could not tolerant the macular buckle, the implanted device will be removed;
  7. Specially assigned staff (Jinge Lu) is responsible for data collection, data management, adverse events reporting, and participant communication.
Being tested
macular buckle
Keywords
macular buckle, high myopia, posterior staphyloma

What participants receive

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

  • macular buckleProcedure or surgery

    macular buckle with a three-armed silicone capsule

Study groups in NCT02169635
Study groupRoleWhat they receive
Macula buckleExperimentalMacular buckle: perform episcleral macular buckle surgery using a three-armed silicone capsule to support the posterior staphyloma in high myopia.
Receives: Procedure: macular buckle

What is being measured

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

  1. best corrected visual acuity

    Measured: 6 months

Secondary outcomes (2)

  1. postoperative complications

    Measured: 6 months

  2. Optical coherence tomography

    Using optical coherence tomography to observe the macular area postoperatively.

    Measured: 6 months

Timeline

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

  1. First posted23 Jun 2014 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02169635
Sponsor's protocol ID
2013meky013
Acronym
MBTAS
Status last verified
Jun 2014
First submitted
17 Jun 2014
Last updated
23 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Parolini B, Frisina R, Pinackatt S, Mete M. A new L-shaped design of macular buckle to support a posterior staphyloma in high myopia. Retina. 2013 Jul-Aug;33(7):1466-70. doi: 10.1097/IAE.0b013e31828e69ea. No abstract available.

    PubMed 23619638

  • Ward B. Degenerative myopia: myopic macular schisis and the posterior pole buckle. Retina. 2013 Jan;33(1):224-31. doi: 10.1097/IAE.0b013e31826d3a93. No abstract available.

    PubMed 23190923

  • Devin F, Tsui I, Morin B, Duprat JP, Hubschman JP. T-shaped scleral buckle for macular detachments in high myopes. Retina. 2011 Jan;31(1):177-80. doi: 10.1097/IAE.0b013e3181fc7e73. No abstract available.

    PubMed 21102364

  • Ward B, Tarutta EP, Mayer MJ. The efficacy and safety of posterior pole buckles in the control of progressive high myopia. Eye (Lond). 2009 Dec;23(12):2169-74. doi: 10.1038/eye.2008.433.

    PubMed 19229272

  • Alkabes M, Pichi F, Nucci P, Massaro D, Dutra Medeiros M, Corcostegui B, Mateo C. Anatomical and visual outcomes in high myopic macular hole (HM-MH) without retinal detachment: a review. Graefes Arch Clin Exp Ophthalmol. 2014 Feb;252(2):191-9. doi: 10.1007/s00417-013-2555-5. Epub 2014 Jan 3.

    PubMed 24384802

Questions about this trial

What is this clinical trial studying?

A study testing macular buckle in people with High Myopia and Posterior Staphyloma, 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 3 inclusion and 7 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 23 Jun 2014. 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?

best corrected visual acuity (time frame: 6 months). 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 NCT02169635, which also lists 5 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 23 Jun 2014.

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