Epiretinal Proliferation in Eyes With Full Thickness Macular Hole

Macular Disease Clinical Trial

Official title:

Epiretinal Proliferation in Eyes With Full Thickness Macular Hole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376776
• Other study ID #: Kyorineye024
• Status: Completed
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 13, 2017
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Description:

We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Eyes with macular hole

Exclusion Criteria:

• Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy

Related Conditions & MeSH terms

• Macular Disease
• Retinal Perforations

Intervention

Procedure:
• Vitrectomy

Locations

Country	Name	City	State
Japan	Makoto Inoue	Mitaka-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of foveal microstructure		6 months
Secondary	Visual improvement		6 months