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    Foldable IOL findings favorable

    Vancouver, BC—Data from 4 years of follow-up in a Canadian prospective clinical trial investigating an acrylic, foldable, single-piece angle-supported phakic IOL (AcrySof Cachet, Alcon) for the treatment of moderate to high myopia demonstrate the procedure is associated with stable visual acuity and refractive outcomes and a low rate of adverse events, said Simon P. Holland, MD.

    “The long-term effect on the corneal endothelium has been the major safety issue with rigid anterior chamber phakic IOLs and remains the big unanswered question for this foldable angle-supported lens,” said Dr. Holland, clinical professor of ophthalmology, University of British Columbia, Vancouver. “Endothelial cell density (ECD) changes so far have been acceptable, but the duration of the study has been extended from its original length of 3 years to 5 years in order to understand endothelial safety [better].

    “My personal experience as a surgeon is that the lens was very easy to implant once the learning curve was overcome, and I consider the stability of the UCVA and MRSE outcomes remarkable,” he said. “Further data on endothelial cell loss are needed, but based on the efficacy, safety, and predictability achieved so far, I think clinicians will appreciate having the option of offering this phakic IOL.”

    There are five investigators participating in the Canadian arm of the AcrySof Cachet Phakic IOL—Simon Holland, MD, Thaddeus Demong, MD, Mihai Pop, MD, Theodore Rabinovitch, MD, and Francis Roy, MD. Eligible patients were adults ages 18 to 49 years old with stable, moderate to high myopia, good general and ocular health, and preoperative logMAR BSCVA of 0.3 or better. Patients with any evidence of cataract, astigmatism >2 D, anterior chamber depth <3.2 mm measured from the corneal epithelium, mesopic pupil diameter >7.0 mm, and ECD below age-based criteria were excluded.

    A total of 120 patients were enrolled. The IOL was implanted using the Monarch II IOL Delivery System (Alcon). Outcomes analyses were based on data from the first eye to undergo implantation for each patient, and visual acuity and MRSE data at 4 years were available for 94 eyes.

    Serial data from visits at 1, 2, 3, and 4 years showed excellent stability of mean UCVA and BCVA. At the 4-year visit, UCVA was 20/20 or better in 64% of eyes and 20/40 or better in 95%; BCVA at 4 years was 20/20 or better in 97% of eyes and 20/25 or better in 100%.

    “The difference between the UCVA and BCVA outcomes reflects the impact of residual cylinder as patients were enrolled with up to 2 D of pre-existing astigmatism,” Dr. Holland commented.

    Mean preoperative MRSE was –10.60 D ± 2.13 D, which reflects that the study population predominantly comprised patients with high/extreme myopia versus moderate myopia. At 1 year, mean MRSE was –0.32 D ± 0.50 D and it was stable thereafter with a mean of –0.38 D ± 0.51 D at 4 years.

    Annualized change in ECD in the central and peripheral regions was calculated using data from the 6-month visit forward in order to exclude for loss caused by surgical trauma. Data based on 4 years of follow-up had not yet been released, but from 6 months to 3 years, the mean annualized ECD loss was 1.4% in the central cornea and 2% in the periphery.

    The most common adverse events were synechia in six (5.0%) eyes and elevated IOP requiring treatment in four (3.3%) eyes, which was not clinically significant. The IOP elevations occurred early after surgery and represented a steroid response in eyes that received a prolonged postoperative corticosteroid treatment, Dr. Holland said. Pupil ovalization, lens dislocation, and cataract each occurred in two eyes (1.7%).

    Secondary surgical interventions comprised IOL repositioning in the two eyes with dislocation, two removals (1.7%), one in a patient with a 7.0-mm pupil who complained of glare and the other for ECD beyond that expected. In addition, there were single patients that underwent preventive iridotomy, intravitreal injection for BRVO, not attributed to the lens, and prophylactic treatment of a retinal tag.

    Other than as an investigator, Dr. Holland receives no financial support from Alcon.

    For more articles in this issue of Ophthalmology Times eReport, click here.

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