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Macular Detachment Associated With Intrachoroidal Cavitation

Primary Purpose

Macular Detachment, Macular Retinoschisis, Intrachoroidal Cavitation

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vitrectomy
Sponsored by
Kyorin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Detachment focused on measuring Macular detachment, Macular retinoschisis, Vitrectomy

Eligibility Criteria

10 Years - 95 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eyes with macular detachment or macular retinoschisis

Exclusion Criteria:

  • Optic pit maculopathy, vitreomacular traction syndrome

Sites / Locations

  • Kyorin Eye Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Vitrectomy

Arm Description

Vitreous surgery to treat macular detachment

Outcomes

Primary Outcome Measures

Visual acuity
The numbers of the patients with visual recovery after surgical intervention

Secondary Outcome Measures

Optical coherence tomography
Anatomical improvement detected with optical coherence tomography after surgical intervention

Full Information

First Posted
October 7, 2013
Last Updated
October 8, 2013
Sponsor
Kyorin University
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1. Study Identification

Unique Protocol Identification Number
NCT01959724
Brief Title
Macular Detachment Associated With Intrachoroidal Cavitation
Official Title
Macular Detachment Associated With Intrachoroidal Cavitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyorin University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of clinical characteristics and surgical outcome for macular detachment associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Detachment, Macular Retinoschisis, Intrachoroidal Cavitation
Keywords
Macular detachment, Macular retinoschisis, Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitrectomy
Arm Type
Other
Arm Description
Vitreous surgery to treat macular detachment
Intervention Type
Other
Intervention Name(s)
Vitrectomy
Primary Outcome Measure Information:
Title
Visual acuity
Description
The numbers of the patients with visual recovery after surgical intervention
Time Frame
one year
Secondary Outcome Measure Information:
Title
Optical coherence tomography
Description
Anatomical improvement detected with optical coherence tomography after surgical intervention
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eyes with macular detachment or macular retinoschisis Exclusion Criteria: Optic pit maculopathy, vitreomacular traction syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Inoue, MD
Organizational Affiliation
Kyorin Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyorin Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan

12. IPD Sharing Statement

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Macular Detachment Associated With Intrachoroidal Cavitation

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