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Natacha Bíscaro Junqueira, Leandro Jerez Chaves, Omero Benedicto Poli-Neto, Rodrigo Jorge; Scleral fixation using a hydrophilic four-haptic lens and polytetrafluoroethylene suture: phase I clinical trial. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1663.
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© ARVO (1962-2015); The Authors (2016-present)
To prospectively verify the safety of scleral fixation using Akreos AO60 IOL and Gore-Tex suture.
Prospective evaluation of 24 consecutive patients that underwent Akreos AO60 scleral fixation with Gore-Tex suture. Aphakic patients or patients with dislocated or subluxed IOL, without capsular support, were included and underwent a comprehensive ophthalmic evaluation including ETDRS BCVA, slit-lamp biomicroscopy, applanation tonometry, indirect ophthalmoscopy, specular microscopy, pachymetry and immersion biometry. Main ophthalmic parameters evaluated in the 6 months of follow up were: best-corrected visual acuity (BCVA), corneal edema, anterior chamber cells score, percentage of patients with erosion of the suture through the conjunctiva and endothelial cells density.
The indications for secondary IOL surgery were dislocated or subluxed crystalline lens after trauma in 9/24 (38%), dislocated crystalline lens after complicated cataract surgery in 4/24 (16%), aphakia after complicated cataract surgery in 6/24 (25%) and dislocated or subluxed IOL in 5/24 (21%). The mean ± SE best-corrected logMAR visual acuity was 0.46 ± 0.06 preoperatively and 0.50 ± 0.11 (20/63 Snellen equivalent) after 6 months of follow-up (p = 0.968). Mean postoperative spherical equivalent was -1.1D. Corneal edema was present in 9/24 patients (37.5%) and 0/24 (p = 0.0016) (Figure 1), anterior chamber cells was verified in 5/24 (20.8%) and 0/24 (p = 0.0496), and erosion of the suture through the conjunctiva (Figure 2) was verified in 3/24 (12.5%) and 9/24 (37.5%) (p = 0.0933), 1 week and 6 months after surgery, respectively. The mean ± SD endothelial cells density was 1,833 ± 542.74 cells/mm2 preoperatively and 1,290 ± 552.13 cells/mm2 after 6 months (p=0.0028).The mean ± SE intraocular pressure was 15.5 ± 1mmHg preoperatively and 15.1 ± 0.8mmHg after 6 months of follow-up (p = 0.643). Postoperative complications included ocular hypertension (IOP ≥ 25mmHg) in 12,5% of patients, hypotony (IOP < 5mmHg) in 16,5%, cystoid macular edema and transient vitreous hemorrhage in 8.3%, and herpetic keratitis, retinal detachment, endophthalmitis and transient lens opacification in 4.1%.
Scleral fixation with Akreos and Gore-Tex appears to be safe. However, caution must be taken related to suture exposure and endophthalmitis. Further phase II studies are warranted.
This is a 2020 ARVO Annual Meeting abstract.
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