Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Macular Holes Clinical Trial

Official title:

Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03805763
• Other study ID #: ZZD-Macular Hole
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2019
• Source: Wenzhou Medical University
• Contact: Zongduan Zhang, M.D,PhD
• Phone: +86 13587604949
• Email: zzduan[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 31, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clear diagnosis of macular hole;

• The minimum diameter of the macular hole is >400 µm;

• Without serious systemic disease that make patients can not be operated;

Exclusion Criteria:

• suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;

• opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;

• eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;

• traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;

• having a history of vitrectomy surgery;

• glaucoma in stage of preclinical, severe stenosis or closure;

Related Conditions & MeSH terms

• Macular Holes
• Retinal Perforations

Intervention

Procedure:
• Large extent of ILM Peeling
The extent of ILM peeling is 4DD
• Small extent of ILM Peeling
The extent of ILM peeling is 2DD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condition of postoperative healing of macular holes	postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT)	1 year
Primary	Mean change from baseline in best-corrected visual acuity (BCVA)	Assessed using the ETDRS protocol	1 year
Primary	change from baseline in foveal avascular zone (FAZ) areas and diameter	Assessed on AngioOCT	1 year
Primary	change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels	Assessed on AngioOCT	1 year