Author: David Steel (United Kingdom)
Co-authors: Roxane Hilier, Maged Habib, Teresa Sandinha, Mustafa Khadhim
Purpose
ILM peeling is known to be associated with a number of changes in the inner retina including retinal nerve fibre layer loss (RNFL), sub-acute nerve fibre layer swelling (SANFL), and a disassociated nerve fibre layer appearance (DONFL). Alcon/Grieshaber Finesse ‘shark skin’ forceps have been developed to specifically improve the ease of picking up the ILM atraumatically during membrane peeling. This may reduce inner retinal damage during ILM peeling by reducing associated retinal trauma but this is unproven. Similarly, it is known that surgeon and local ocular factors may be important, but the magnitude and significance of these variables is unknown.
Setting/Venue
Five experienced surgeons in 3 vitreoretinal surgical centres in the UK
Methods
Pilot masked randomised controlled trial of 66 patients undergoing ILM peeling for idiopathic macular hole with conventional ILM peeling forceps as compared to the new Finesse ‘shark skin’ forceps. The study concentrated on objective signs of retinal trauma assessed by masked image assessors of pre and postoperative spectral domain optical coherence tomography, infrared and auto-fluorescent imaging but also assessed surgeon related factors in a questionnaire as well as functional endpoints including visual acuity and visual fields after surgery. Surgeons, postoperative vision and imaging assessors were masked to the type of forceps used. The study also assessed appropriateness of trial design including masking procedures, recruitment, endpoints and adverse events to assess the feasibility and sample size for a definitive study.
Results
66 patients (66 eyes) have been recruited. The mean age was 71 years and 77% of participants were female. The mean minimum linear diameter of the holes was 458 microns, with 40% stage 2, 50% stage 3 and 10% stage 4 holes. 32% had vitreo-foveal attachment. The median hole duration was 6 months, with a mean preoperative visual acuity of 50 ETDRS letters. Primary hole closure was achieved in 63/66 eyes (95%) and mean final visual acuity was 67 letters. No adverse events related to the forceps were recorded. Data on RNFL changes, SANFL, DONFL and visual fields will be presented and related to masked topographical analysis of intraoperative video images. The effect of surgeon, hole phenotype and forceps type will be reported.
Conlusions
The study has fully recruited and will provide key data relating to inner retinal trauma after ILM peeling. Specifically, it will assess whether the use of Finesse 'Shark skin' forceps reduces the occurrence of inner retinal changes after ILM peeling, as compared to conventional ILM forceps. It will also allow discrimination between surgeon, ocular and forceps factors related to inner retinal changes after ILM peeling for idiopathic macular hole.
Financial Disclosure
The study was funded as an IIS by Alcon, with payment to Newcastle University.
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