Comparative Clinical Evaluation Of The Safety And Effectiveness Of Two Models Of A Diffractive Monofocal Extended Depth Of Focus Intraocular Lens

The Monofocal Extended Depth of Focus (Mono-EDoF) IOL is designed to provide similar distance vision and improved intermediate vision compared to a Monofocal IOL. The diffractive technology of the IOL allows most of the light to converge in one focal point thereby providing high quality distance vision and continuous focus to intermediate vision while minimizing the effects of unwanted visual disturbances. The purpose of this study was to compare the safety and effectiveness of two different optical designs, Models ME4 and ME6, as evaluated by clinically measurable differences in visual acuity and visual disturbance.

Ramachandra Eye Institute, Madurai, India 

This prospective, randomized, single-center, comparative clinical study enrolled eligible adult subjects without co-existing ocular pathology and ≤ 1.00 D corneal astigmatism who were candidates for phacoemulsification with IOL implantation. Subjects were randomized in a 1:1 ratio to implantation with either the Mono-EDoF IOL Model ME4 or Model ME6 in both eyes. Fellow eye surgery was scheduled at least two weeks following first eye surgery. Postoperatively, subjects were followed for 6 months.  Assessments included visual acuity at distance and intermediate, contrast sensitivity, defocus curve, VF-14 questionnaire and glare and halo simulation.   

30 eyes / 15 subjects received each IOL (ME4: 11 female, mean age 55.2 years, mean IOL 21.80 D; ME6: 8, 54.7 years, 22.58 D). Mean postoperative spherical equivalent measured -0.18 D in both groups.  Mean monocular UDVA was logMAR 0.17 (ME4) and 0.24 (ME6); 100% (ME4) and 73% (ME6) achieved binocular UDVA logMAR 0.2 or better. 100% of eyes in both groups achieved CDVA logMAR 0.2 or better. 83% and 100% in both groups achieved monocular UCIVA and binocular UCIVA logMAR 0.3 or better at 70 cm, respectively. Mean binocular DCIVA measured logMAR 0.11 D in both groups. Defocus testing showed 1.50 D monocular and 2.00 D binocular range at 0.3 logMAR in both groups. There was no difference in contrast sensitivity or glare/halo between groups.  

ME4 and ME6 Mono-EDoF IOLs demonstrate similar satisfactory uncorrected, and distance corrected intermediate range visual acuity, while ME4 appears to provide better uncorrected distance visual acuity.  Both IOLs provide CDVA equivalent to standard monofocal IOLs. Defocus testing, contrast sensitivity and glare/halo simulation do not reveal significant differences between the two IOL models. Based on comparison with historical data for standard monofocal IOLs, ME4 and ME6 provide at least 0.50 D increased depth of focus and more than one line of improvement in distance corrected visual acuity at intermediate range, without compromising corrected distance visual acuity.