Value of internal limiting membrane peeling in surgery for idiopathic macular hole and the correlation between function and retinal morphology.

Idiopathic macular hole is characterized by a full thickness anatomic defect in the foveal retina leading to loss of central vision, metamorphopsia and a central scotoma. Classic macular hole surgery consists of vitrectomy, posterior vitreous cortex separation and intraocular gas tamponade, but during the past decade focus has especially been on internal limiting membrane (ILM) peeling as adjuvant therapy for increasing closure rates. With increasing use of ILM peeling and indocyanine green (ICG) staining, which is used for specific visualization of the ILM, concerns about the safety of the procedure have arisen. At present, it is not known whether ICG-assisted ILM peeling potentially reduces the functional outcome after macular hole surgery. The purpose of the present PhD thesis was to examine whether ICG-assisted ILM peeling offers surgical and functional benefit in macular hole surgery. We conducted a randomized clinical trial including 78 pseudophakic patients with idiopathic macular hole stages 2 and 3. Patients were randomly assigned to macular hole surgery consisting of (i) vitrectomy alone without instrumental retinal surface contact (non-peeling), (ii) vitrectomy plus 0.05% isotonic ICG-assisted ILM peeling or (iii) vitrectomy plus 0.15% trypan blue (TB)-assisted ILM peeling. Morphologic and functional outcomes were assessed 3, 6 and 12 months after surgery. The results show that surgery with ILM peeling, for both stages 2 and 3 macular holes, is associated with a significantly higher closure rate than surgery without ILM peeling (95% versus 45%). The overall functional results confirm that surgery for macular hole generally leads to favourable visual results, with two-thirds of eyes regaining reading vision (>or=20/40). Macular hole surgery can be considered a safe procedure with a low incidence of sight-threatening adverse events; the retinal detachment rate was 2.2%. Visual outcomes in eyes with primary hole closure were not significantly different between the intervention groups; however, for the stage 2 subgroup with primary macular hole closure, there was a trend towards a better mean visual acuity in the non-peeling group (78.2 letters) compared to the ICG-peeling group (70.9 letters), p = 0.06. Performing repeated macular hole surgery was associated with a significant reduction in functional outcome indicating that primary focus should be on closing the macular hole in one procedure. Morphological studies of closed macular holes with contrast-enhanced optical coherence tomography (OCT) found thinning and discontinuity of the central photoreceptor layer matrix that were highly specific for predicting the likelihood of an eye having regained reading vision 12 months after macular hole surgery. Additionally, healing after macular hole surgery appeared to begin with the contraction of the inner aspect of the retina, forming a roof over a subfoveal fluid-filled cavity, and to end with a gradual restoration of the anatomy in the outer layers of the retina at the junction of the photoreceptor inner and outer segments. We found the more intact this structure was on contrast-enhanced OCT 3 months after macular hole surgery, the better the visual acuity after 12 months, whereas late rather than early resolution of subfoveal fluid had no impact on final visual outcome. The use ILM peeling and intraoperative dyes did not have any functionally important effects on postoperative macular structure. Based on the above findings, we conclude that ILM peeling should be performed in all cases of full thickness macular hole surgery. The use of 0.05% intraoperative isotonic ICG with short exposure time appears to be a safe alternative in stage 3 macular hole surgery, whereas a slight reduction in functional potential not can be excluded when performing 0.05% isotonic ICG-assisted ILM peeling in stage 2 macular hole surgery.

RCT Entities:   Population Interventions Outcomes