NCT02169635

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

June 17, 2014

Last Update Submit

June 18, 2014

Conditions

High MyopiaPosterior Staphyloma

Keywords

macular bucklehigh myopiaposterior staphyloma

Outcome Measures

Primary Outcomes (1)

  • best corrected visual acuity

    6 months

Secondary Outcomes (2)

  • postoperative complications

    6 months

  • Optical coherence tomography

    6 months

Other Outcomes (1)

  • intraocular pressure

    6 months

Study Arms (1)

Macula buckle

EXPERIMENTAL

Macular buckle: perform episcleral macular buckle surgery using a three-armed silicone capsule to support the posterior staphyloma in high myopia.

Procedure: macular buckle

Interventions

macular bucklePROCEDURE

macular buckle with a three-armed silicone capsule

Macula buckle

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

  • 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.

    PMID: 23619638BACKGROUND

  • 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.

    PMID: 23190923BACKGROUND

  • 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.

    PMID: 21102364BACKGROUND

  • 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.

    PMID: 19229272BACKGROUND

  • 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.

    PMID: 24384802BACKGROUND

Study Officials

  • Lin Lu, MD, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Fundus Disease Center of Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 23, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

CN(1)