Evaluation of anterior chamber depth, endothelial cell loss, and safety following optic exchange of a modular intraocular lens

Session Details

Session Title: Presented Poster Session: After Surgery

Venue: Poster Village: Pod 1

First Author: : R.Ang PHILIPPINES

Co Author(s): :    R. Williams   R. Suryakumar                    

Abstract Details

Purpose:

Evaluate safety and effectiveness after primary implantation and exchange of HARMONI Modular Intraocular Lens (HMIOL).

Setting:

Asian Eye Institute, Makati City, Philippines

Methods:

Prospective, multi-center study: 116 subjects implanted with HMIOL in study eye targeted for monovision, and monofocal IOL in contralateral eye (control), targeted for emmetropia (eyes=114). Subjects could elect optic exchange 3 months post-implantation. Manifest refraction spherical equivalent (MRSE), percent change in endothelial cell count (ECC), and adverse event (AE) were reported pre- and post-optic exchange. For a subset of eyes (HMIOL, n=26; control, n=36), anterior chamber depth (ACD) was measured at day 0, week 1, and month 3.

Results:

65 eyes received optic exchange. Mean MRSE changed from −1.24±0.58 D pre-exchange to −0.53±0.70 D post-exchange at month 3. ECC change from baseline was −4.2% for HMIOL eyes 3-months after primary implantation; post-exchange −2.7% at month 3 and −3.2% at month 6, significantly below specified 14% threshold (P<0.001). 0 to month 3 absolute change in ACD ≤350 µm was 96% for HMIOL eyes and 81% for control (P<0.001). Most commonly reported AE was dry eye: 2% pre-exchange and 9% after exchange.

Conclusions:

Refractive outcomes can be modified with an HMIOL exchange. Percent change in ECC after optic exchange was significantly below the pre-specified threshold. ACD results indicated significantly better axial stability of HMIOL compared with control. No unanticipated AEs were reported and no additional risks were identified.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented