NCT03525899|Completed
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Sponsor study identifier
observational
7
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
December 1, 2017
Actual (reported)Study Completion
December 1, 2017
Actual (reported)To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2017
Actual (reported)December 1, 2017
Actual (reported)December 1, 2017
Actual (reported)April 8, 2018
Actual (reported)May 16, 2018
Actual (reported)Time to macular hole closure
Evaluation by optical coherence tomography
OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year
Best corrected visual acuity
One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.
Recruited patients included, the persistent MH group, who had MH before the primary DV, and the newly-developed MH group, who developed MH after a successful primary DV
Pars plana vitrectomy combined with Internal limiting membrane peeling, inverted internal limiting membrane flap insertion into the macular hole, or lens anterior or posterior capsular flap insertion into the macular hole
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients from January 2010 to May 2017 treated by a single surgeon (Y.C.M) at National Taiwan University Hospital were retrospectively reviewed.
Department of Ophthalmology, National Taiwan University Hospital
Taipei, 100, Taiwan
Yeh PT, Cheng CK, Chen MS, Yang CH, Yang CM. Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation. Retina. 2009 Mar;29(3):355-61. doi: 10.1097/IAE.0b013e31818c3251.
Chen SN, Yang CM. LENS CAPSULAR FLAP TRANSPLANTATION IN THE MANAGEMENT OF REFRACTORY MACULAR HOLE FROM MULTIPLE ETIOLOGIES. Retina. 2016 Jan;36(1):163-70. doi: 10.1097/IAE.0000000000000674.
Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. doi: 10.1097/00006982-200204000-00007.
Chung-May Yang, MD
National Taiwan University Hospital
7 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2018
First Posted
May 16, 2018
Study Start
November 1, 2017
Actual (reported)Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Contact the study team to confirm eligibility.
Primary Completion
December 1, 2017
Actual (reported)Study Completion
December 1, 2017
Actual (reported)Last Updated
May 16, 2018
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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