April 25, 2005
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Lenstec accommodative IOL showed little change but high patient satisfaction in trials

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WASHINGTON — An accommodative IOL produced “relatively small” objective accommodative change in clinical trials, but investigators said the level of patient satisfaction with the IOL was high.

“Patients had an objective improvement in their accommodation of about 0.6 D, but their subjective amplitude of accommodation was 2.1 D or greater,” Sunil Shah, MD, FRCS, told attendees at the American Society of Cataract and Refractive Surgery meeting. He presented results a 6-month study of 65 patients implanted with the Kellan Tetraflex KH3500 lens from Lenstec.

Dr. Shah said that one patient in particular, his father, was “very happy” with his visual outcomes.

A 200-patient study of the KH3500 IOL, presented by Sanjay Mantry, MD, FRCS, found similar results.

“Patients’ subjective grading of their functional accommodation was much higher compared to objective results,” Dr. Mantry said. Patients in his study reported having a mean functional accommodation of 2.1 D, ranging up to 5 D of reported accommodation. Postoperative best corrected visual acuity in the trial averaged approximately 20/25.

Deepak K. Chitkara, FRCOphth, said that 75% of patients in a 138-patient study reported being “very satisfied” with their vision after implantation with the KH3500 lens, and more than 45% of patients reported achieving functional vision that was equivalent to more than 3 D of accommodation. Uncorrected distance visual acuity of 20/40 was achieved in 70% of patients, he said.

Regarding the investigators’ observation that patients implanted with the KH3500 lens experienced little accommodative shift as measured objectively -- under 1 D in most cases – but reported significant subjective improvement, Dr. Shah said, “We are a long way from seeing how these lenses actually work, but the patients continue to be happy, and that’s really what matters.”