Inverted Flap Versus Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Full Thickness Macular Hole Clinical Trial

Official title:

Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04498624
• Other study ID #: 0062156
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2020
• Source: University of Turin, Italy
• Contact: MIchele Reibaldi, MD
• Phone: 0116331863
• Email: michele.reibaldi[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• idiopathic full thickness macular hole = 350 micron of diameter

• phakic or pseudophakic

• absence of systemic adverse conditions

Exclusion Criteria:

• concomitant retinal and other ocular disease

• previous ocular surgery except cataract surgery

• axial length >26mm

Related Conditions & MeSH terms

• Full Thickness Macular Hole
• Retinal Perforations

Intervention

Procedure:
• inverted flap
full thickness macular hole surgery
• peeling internal limiting membrane (ILM)
full thickness macular hole surgery

Locations

Country	Name	City	State
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microperimetry retinal sensitivity	Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique	3 months
Secondary	Best corrected visual acuity (BCVA)	Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique	3 months
Secondary	Closure rate	Closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique	3 months