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Scleral spacing technique improves reading vision at 6 months in phase 2 trial
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DALLAS — A surgical treatment for presbyopia appeared to safely improve reading vision in patients followed for 6 months in a clinical trial, according to a press release.
In a phase 2 study of the Scleral Spacing Procedure for the treatment of presbyopia, 44 treated eyes were compared with 23 randomized, nonsurgical control patients, according to Refocus Group Inc. Both groups were monitored for reading and near acuity vision using standard near vision reading charts preoperatively and at the 3- and 6-month intervals after surgery. Those who underwent the surgical procedure gained a median of three lines of near visual acuity at 6 months. “Several patients” showed improvement of five lines or more, the Refocus Group said in its press release.
About 90% of the patients who underwent the surgery reported their near vision was “either better or significantly better,” the press release said. No patient in either group showed deterioration of uncorrected distance acuity or contrast sensitivity.
The Scleral Spacing Procedure uses four scleral implants, each about the size of a grain of rice, implanted just under the surface of the sclera in four quadrants. The procedure is the same, whether it is used to treat presbyopia, glaucoma or ocular hypertension, the company noted. In presbyopia, the procedure is said to “reduce the crowding of the underlying tissues surrounding the crystalline lens, allowing the muscles to once again naturally reshape the lens and accommodate the eye,” the Refocus release said.