A retrospective chart review was performed of all patients who underwent scleral fixation of an Akreos AO60 (Bausch and Lomb, Bridgewater, NJ, USA) IOL using CV-8 (USP 7–0) Gore-Tex suture (W.L. Gore & Associates, Newark, DE, USA) by a PGY4 resident or fellow under supervision of a single attending (F.A.W.) at Johns Hopkins Wilmer Eye Institute from November 1, 2015 (initial adoption of technique) to August 31, 2018. This study was carried out in adherence to the Declaration of Helsinki and was approved by the Institutional Review Board of our institute in which requirement for informed consent was waived due to the retrospective nature of the study. All work was compliant with the Health Insurance Portability and Accountability Act (HIPAA). All patients were identified from surgical operative reports for current procedural terminology (CPT) codes 66,985 (insertion of IOL prosthesis, secondary implant, not associated with concurrent cataract removal), 66,682 (suture to the iris or ciliary body during cataract removal), 66,986 (exchange of IOL), and 66,825 (repositioning of an IOL prosthesis).
Patient records meeting the above criteria were reviewed, and the following baseline preoperative data were collected: age at time of surgery, gender, surgery date, eye laterality, reason for loss of capsular support (ie surgical complication, trauma, pseudoexfoliation, Marfan syndrome), best-corrected visual acuity (BCVA), manifest refraction, keratometry, and axial length. Conventional biometry was used for IOL calculations and expected postoperative spherical equivalent (SE) was calculated using the Sanders-Retzlaff-Kraff theoretical (SRK/T) formula assuming sulcus IOL location. If trauma or other anatomic factors precluded this, ultrasound biometry utilizing keratometry values of the fellow eye was used for IOL power calculations.
Intraoperative data collected included: IOL power implanted, sclerotomy location (measured in mm behind limbus), whether combined with pars plana vitrectomy (PPV) and gauge of trocar used to make sclerotomy incisions, and intraoperative complications. Postoperative BCVA on all time points available, which typically included day 1, week 1, month 1, month 3, month 6, and one year, as well as BCVA at last follow-up, were collected. Other postoperative data collected included: intraocular pressure (IOP) at day 1, week 1, month 1, and last follow-up, duration of follow-up period, and manifest refraction. All postoperative complications were recorded. Hypotony was defined as a new onset of an IOP of ≤ 6 mm Hg at postoperative day 1, week 1, month 1, or last-follow-up, which was based on the World Glaucoma Association guidelines.21 Cystoid macular edema was defined as new-onset postoperative macular edema that was confirmed with spectral domain optical coherence tomography (OCT). OCT imaging of the macula was routinely performed at the postoperative month 1 visit in all cases and at other time points when clinically indicated. Corneal edema was defined as new-onset postoperative edema that persisted >1 month.
Snellen visual acuities were converted to logarithm of the minimum angle of resolution (logMAR) equivalents. The primary outcome measures were best postoperative BCVA, change in BCVA, difference between expected and final spherical equivalent (SE), and postoperative complications. Using Stata software (StataCorp LLC, College Station, TX, USA) and R 3.5.0 (R Core Team, Vienna, Austria) to compute paired Student’s t test analysis or Fisher’s exact test, a p-value < 0.05 was considered statistically significant.
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