Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03805763
Other study ID # ZZD-Macular Hole
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT04535622 - Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery N/A
Completed NCT03572725 - Air Tamponade and Non-supine Positioning in Macular Hole Surgery. N/A
Completed NCT01471912 - Elongation of Foveal Tissue After Macular Hole Surgery N/A
Completed NCT03646695 - ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study N/A
Completed NCT06323902 - Autologous Platelet-rich Plasma as a Treatment for Macular Holes
Completed NCT01974310 - Postoperative Positioning After Surgery for Macular Holes N/A
Completed NCT00537992 - Blue-Blocking IOLs in Combined Surgery N/A
Completed NCT05171621 - Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
Recruiting NCT06000111 - Duration of Face Down Positioning for Full-Thickness Macular Hole Repair N/A
Recruiting NCT04135638 - Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison N/A
Completed NCT03525899 - Macular Hole After Diabetic Vitrectomy
Completed NCT03917602 - Human Amniotic Membrane Plug for Large Macular Holes N/A
Completed NCT04527848 - Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery Phase 4
Recruiting NCT04116892 - Comparative Analysis of Large Macular Hole Surgeries N/A
Completed NCT01229657 - Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes N/A
Completed NCT01381965 - Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery N/A
Completed NCT01306487 - Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery N/A
Completed NCT03174639 - High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps N/A
Recruiting NCT05083650 - Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis N/A