Optical Coherence Tomography-based Positioning for Macular Hole Surgery

NCT02650739 — Completed, 125 participants, Kyorin University
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Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography

RegistryNCT02650739
StatusCompleted
Study typeObservational
Enrollment125 (Actual)
SponsorKyorin University (Other)
ConditionsMacular Hole Surgery
InterventionsMacular hole surgery (Procedure)
Datesstart 2013-05-01, primary completion 2015-08-01, completion 2015-10-01, first posted 2016-01-08, last updated 2016-01-08

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All trials for Macular Hole Surgery All trials of Macular hole surgery

-Summary

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.

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+Detailed description

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.

+Arms and interventions

ArmTypeInterventionsDescription
SS-OCTdetermined groupProcedure: Macular hole surgeryEyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT
Control groupProcedure: Macular hole surgeryEyes with macular hole surgery that the halting of the prone position was determined by the surgeon
  • Macular hole surgery (Procedure), also known as Vitrectomy: Vitrectomy with internal limiting membrane removal and gas tamponade

+Outcome measures

Primary outcomes

  • Macular hole closure [Changes from baseline to 1, 2 months]: Closure of macular hole

Secondary outcomes

  • Visual acuity before and after surgery [Changes from baseline to 1, 2 months]: Vision

+Eligibility

Sex: All, ages: 20 Years to 90 Years

Inclusion Criteria:

* The patients were followed more than 2 months.

Exclusion Criteria:

* Eye with axial length more than 26.0 mm

+Investigators