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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03805763

Enrollment

Registered

2019-01-16

Start date

2019-02-01

Completion date

2020-01-31

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Holes

Brief summary

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

Interventions

PROCEDURELarge extent of ILM Peeling

The extent of ILM peeling is 4DD

PROCEDURESmall extent of ILM Peeling

The extent of ILM peeling is 2DD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Contacts

Primary ContactZongduan Zhang, M.D,PhD

zzduan@yeah.net+86 13587604949

Backup ContactQintuo Pan, M.D

panqintuo@qq.com-86 13958851073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026