Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial.
OBJECTIVE
To determine the effect of internal limiting membrane (ILM) peeling on anatomical and functional success rates in stage 2 and 3 idiopathic macular hole surgery (MHS).


METHODS
Randomised clinical trial of stage 2 and 3 idiopathic macular hole without visible epiretinal fibrosis and with less than 1 year's duration of symptoms. Eyes were randomised to (1) vitrectomy alone without retinal surface manipulation, (2) vitrectomy plus 0.05% isotonic Indocyanine Green (ICG)-assisted ILM peeling or (3) vitrectomy plus 0.15% Trypan Blue (TB)-assisted ILM peeling. Main outcomes were hole closure after 3 and 12 months and best-corrected visual acuity after 12 months.


RESULTS
78 eyes were enrolled. Primary closure rates were significantly higher with ILM peeling than without peeling for both stage 2 holes (ICG peeling 100%, non-peeling 55%, p = 0.014) and for stage 3 holes (ICG peeling 91%, TB peeling 89%, non-peeling 36%, p<0.001). Visual outcomes in eyes with primary hole closure were not significantly different between the groups.


CONCLUSIONS
Dye-assisted ILM peeling was associated with significantly higher closure rates than non-peeling in both stage 2 and 3 MHS. Intraoperative ILM staining with 0.05% isotonic ICG was not associated with a significantly different visual outcome than non-peeling or TB peeling in eyes with primary hole closure.


BACKGROUND
NCT00302328.
Christensen
U C
UC
Department of Ophthalmology, Glostrup Hospital, Nordre Ringvej 57, DK-2600 Glostrup, Denmark. ulrikchristensen@dadlnet.dk
Krøyer
K
K
Sander
B
B
Larsen
M
M
Henning
V
V
Villumsen
J
J
la Cour
M
M
D000368:Aged; D004396:Coloring Agents; D019773:Epiretinal Membrane / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007208:Indocyanine Green; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012167:Retinal Perforations / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D016896:Treatment Outcome; D014343:Trypan Blue; D014792:Visual Acuity; D014821:Vitrectomy / Q000379:methods
D004396:Coloring Agents; D014343:Trypan Blue; D007208:Indocyanine Green