Optical Coherence Tomography-based Positioning for Macular Hole Surgery

Macular Hole Surgery Clinical Trial

Official title:

Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650739
• Other study ID #: Kyorineye0021
• Status: Completed
• Phase: N/A
• First received: January 6, 2016
• Last updated: January 6, 2016
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• The patients were followed more than 2 months.

Exclusion Criteria:

• Eye with axial length more than 26.0 mm

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Hole Surgery
• Retinal Perforations

Intervention

Procedure:
• Macular hole surgery
Vitrectomy with internal limiting membrane removal and gas tamponade

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular hole closure	Closure of macular hole	Changes from baseline to 1, 2 months	No
Secondary	Visual acuity before and after surgery	Vision	Changes from baseline to 1, 2 months	No