June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Scleral fixation using a hydrophilic four-haptic lens and polytetrafluoroethylene suture: phase I clinical trial
Author Affiliations & Notes
  • Natacha Bíscaro Junqueira
    Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, University of São Paulo Ribeirão Preto College of Medicine, Andradina , São Paulo, Brazil
  • Leandro Jerez Chaves
    Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, University of São Paulo Ribeirão Preto College of Medicine, Andradina , São Paulo, Brazil
  • Omero Benedicto Poli-Neto
    University of São Paulo Ribeirão Preto College of Medicine, Brazil
  • Rodrigo Jorge
    Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, University of São Paulo Ribeirão Preto College of Medicine, Andradina , São Paulo, Brazil
  • Footnotes
    Commercial Relationships   Natacha Junqueira, None; Leandro Chaves, None; Omero Poli-Neto, None; Rodrigo Jorge, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 1663. doi:
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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)

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Abstract

Purpose : To prospectively verify the safety of scleral fixation using Akreos AO60 IOL and Gore-Tex suture.

Methods : 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.

Results : 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%.

Conclusions : 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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