Macular Holes Clinical Trial
Official title:
Extent of Internal Limiting Membrane Removal and Its Impact on Outcomes of Macular Hole Surgery
Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were equally randomized to small extent group or large extent group depending on the extent of internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary analysis was conducted to identify the difference of functional and anatomical outcomes between the two groups. Subsequent analysis was performed to reveal the relationship between the functional and anatomical outcomes.
This randomized clinical trial was performed at a single center. Patients who were scheduled
for surgery for idiopathic macular hole (MH) were enrolled. Eligible patients were equally
randomized to small extent group or large extent group depending on the extent of ILM to be
removed. Random numbers were generated through computerized block-randomization.
A standard 3-port pars plana vitrectomy was performed by a single surgeon using 23-gauge
vitrectomy system, with a 1-step scleral tunnel incision. After posterior vitreous
detachment was achieved, peeling of the ILM was performed by an end gripping forceps with
the assistance of indocyanine green dye. The ILM was peeled in round shape with the radius
of either 0.75-disc diameter or 1.5-disc diameter centering at the center of the MH
according to the pre-assigned group. This was followed by a complete fluid-gas exchange, and
all patients were encouraged to maintain a face-down position for at least 5 days
postoperatively.
Postoperative measurements of BCVA and M-score were conducted at 2- and 6-month follow-up
visits by independent masked observers. The first postoperative SD-OCT scanning was usually
conducted at 1 to 2 weeks after operation according to the intraocular gas status. Then, OCT
scans were conducted at follow-up visits 2, and 6 months postoperatively. The same
experienced examiner conducted all the OCT scans on all subjects.
Comparison of anatomical closure, BCVA, M-score, Δ BCVA, and Δ M-score were primarily
performed between the two groups. Then, the parameters measured from OCT scans with changes
in ETDRS visual acuity and M-score were analyzed.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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