New recommendations released for specular microscopy for phakic IOLs

Issue: January 10, 2017

An American Academy of Ophthalmology task force released new recommendations and more details than currently available guidelines on the management of specular microscopy for evaluation of phakic IOLs.

The task force recommended using specular microscopy preoperatively and at the 6-, 12-, 24- and 36-month postoperative intervals after implantation of a phakic IOL. Preoperatively there should be a minimum of six scans with good images, and a minimum of three scans with good images should be taken at each follow-up point. Endothelial cell loss of 25% or more from preoperative cell density may be a clinical investigation endpoint for a new phakic IOL, according to the consensus statement.

“A 20% endothelial cell loss or an endothelial cell count of <1,500 cells/mm² should trigger recalling the subject and retesting the specular microscopy to confirm the cell loss or count. Serial specular microscopies can be performed on eyes of concern every 4 to 6 months to evaluate the cell density stability. For these eyes, if there appears to be an accelerated annual cell loss rate above 1%/year, then implant removal may be considered,” the task force members wrote.

The data should be examined at a reading center within 90 days of when the specular microscopy is performed. If the endothelial cell density decreases 20% or more or falls below 1,500 cells/mm², the investigator should be notified, according to the recommendations.

“The sponsor should also report annually to the investigator any eyes that have a 15% or higher cell density decrease from the preoperative value,” the task force members wrote.

Disclosure: MacRae reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.

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Source:

MacRae S, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.09.034.