Clinical trial NCT03525899: Macular Hole After Diabetic Vitrectomy
Official title: Macular Hole After Diabetic Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proliferative Diabetic Retinopathy
Macular Holes
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from January 2010 to May 2017 treated by a single surgeon (Y.C.M) at National Taiwan University Hospital were retrospectively reviewed.

Brief summary: To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).

Detailed description: All patients had received initial vitrectomy to treat complications of PDR. Recruited patients were divided to two groups: the persistent MH group, who had MH before the primary DV (group 1); and the newly-developed MH group, who developed MH after a successful primary DV (group 2). The patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as MH repairing techniques. The extent of fibrovascular proliferation(FVP) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). The extent of retinal detachment (RD) was classified into "within the arcade" or "beyond the arcade". The macular structure was evaluated by optical coherence tomography (OCT). All patients had a follow-up duration of more than three months after the final surgical procedures.

Three different surgical techniques were used to treat MH: standard internal limiting membrane (ILM) peeling, inverted ILM flap insertion into the MH, and lens anterior or posterior capsular flap insertion into the MH. The indication(s) for each technique were:

standard ILM peeling was performed if no ILM peeling had been done in the previous surgery, and the MH size was less than 500um in an attached retina; inverted ILM flap insertion was performed if no ILM peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ILM tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ILM tissue available. Only descriptive statistics was obtained.

Eligibility criteria: Inclusion Criteria:

* Proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy
* The persistent MH group after surgery, who had MH before the primary DV
* Newly-developed MH group, who developed MH after a successful primary diabetic retinopathy

Exclusion Criteria:

* Patients with peripheral breaks
* Patients with macular hole before surgery, which closed after primary diabetic retinopathy
* Missing clinical data

Primary outcomes:
measure: Time to macular hole closure
timeFrame: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Ophthalmology, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chung-May Yang, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. doi: 10.1097/00006982-200204000-00007.