Initial outcomes of a new generation, AI designed spiral optic, non-diffractive multifocal IOL

EXAMINATION PROTOCOL AND STUDY TECHNIQUE

Before the surgery, all patients will undergo a complete ophthalmologic examination including manifest refraction, slit lamp biomicroscopy, noncontact tonometry (Tomey), macular OCT (Optovue, Fremont, USA) and dilated fundus examination. Biometric assessments will be performed using the swept source OCT based optical biometer, IOL Master-700, using the Barrett’s Total Keratometry (TK) formula and Corneal topography (pentacam). All eyes will be targeted at emmetropia.

 Post-operative assessment will be done on postoperative visits at day 1, 2 weeks, 3 months and 12 months following surgery. Primary clinical tests included manifest refraction (sphere, cylinder and spherical equivalent), uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA) measured with ETDRS charts at 60 and 80cm monocularly and binocularly, corrected intermediate visual acuity (CIVA) at 60 and 80 cm, distance corrected near visual acuity (DCNVA) and uncorrected near vision acuity (UNVA) measured with ETDRS chart at 33 and 40 cm monocularly and binocularly. Secondary clinical tests included binocular corrected defocus curves at postoperative 2 weeks, 3 and 12 months of follow-up, rate of development of Posterior Capsular Opacification (PCO), contrast sensitivity (mesopic) using CSV 1000, reading speeds using Salzburg Reading Desk (SRD) at postoperative visit 3 and 12 months follow-up, photic phenomenon by dysphotopsia questionnaire at postoperative 3 and 12 months follow-up, patient satisfaction and spectacle independence questionnaire at postoperative visit 3 and 12 months follow-up and documentation of adverse events at all four postoperative visits.

 Surgical Procedure

Cataract surgery will be performed by a single experienced  surgeon (S.G.) under topical anaesthesia with 0.5% proparacaine hydrochloride. A clear corneal incision measuring 2.8mm will be made in the temporal limbus then a continuous curvilinear capsulorrhexis measuring 5.0-5.5 mm will be performed (phacoemulsification) or LENSAR/Zeimer machine will be used for FLACS, following which, hydrodissection will be done. The nucleus will then be phacoemulsified. Residual cortex will be removed followed by injection of viscoelastic material (hydroxymethylpropylcellulose 2%) into the anterior chamber. The Rayner galaxy lens will then be injected into the bag and remaining viscoelastic material will be removed. All surgical incisions will be confirmed to be self-sealing before closure.

All patients will be uniformly started on postoperative medications: prednisolone acetate (1%) administered ever four hours in a weekly regression regimen, preservative-free moxifloxacin (0.5%) every four hours for a week, nepafenac (0.1%) three times daily for two weeks and lubricating sodium hyaluronate (0.1%) four times daily for two months

Postoperative follow-up examinations will be performed by a masked assessor (trained optometrist)  at 1 day, 2 weeks, 3 month and 12 months after surgery. Slit-lamp examination will be performed on the post-op 1 day. The following tests will be performed at all postoperative visits from 2 week onwards: