Macular Hole After Diabetic Vitrectomy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Macular Hole After Diabetic Vitrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525899
• Other study ID #: 201709039RINB
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2017
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Holes
• Proliferative Diabetic Retinopathy
• Retinal Perforations

Intervention

Procedure:
• Pars plana vitrectomy
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

Locations

Country	Name	City	State
Taiwan	Department of Ophthalmology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Best corrected visual acuity	Landolt C chart	One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.