High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps

Retinal Detachment Clinical Trial

Official title:

High Myopia Macular Hole and Retinal Detachment Accepted Internal Limiting Membrane Flip Packing and Free Flap Was the Internal Limiting Membrane (ILM Flap Was Double)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174639
• Other study ID #: 201512113RINA
• Status: Completed
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 31, 2017
• Start date: March 11, 2016
• Est. completion date: June 30, 2016

Study information

• Verified date: May 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed.

Description:

From July 2015 to December 2015, clinical record of 8 consecutive cases of macular hole with retinal detachment in high myopia treated with combined inverted and free ILM flap insertion into the hole were retrospectively reviewed. The anatomical and function outcomes were assessed. Patients with a history of trauma or concurrent peripheral breaks were excluded. The anatomical and function outcomes, including the status of the macular hole and retina were assessed.The study was approved by the ethnic committee and research board.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Macular hole with retinal detachment in high myopia

Exclusion Criteria:

• History of trauma, peripheral retinal breaks

Related Conditions & MeSH terms

• Dissociative Disorders
• High Myopia
• Macular Holes
• Myopia
• Retinal Detachment
• Retinal Perforations

Intervention

Procedure:
• Inverted and free ILM insertion
ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of macular hole	Closure of macular hole demonstrated by optical coherence tomography	3 months
Secondary	Retinal reattachment	Retinal reattachment observed by fundoscopy	3 months