Apodized diffractive lens yields excellent vision in RLE

July 15, 2005

Washington, DC—Refractive lens exchange (RLE) with implantation of the AcrySof SA60D3 ReSTOR IOL (Alcon Laboratories) appears to approach the ideal refractive surgery for the presbyopic age group, said Francesco Carones, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

Washington, DC-Refractive lens exchange (RLE) with implantation of the AcrySof SA60D3 ReSTOR IOL (Alcon Laboratories) appears to approach the ideal refractive surgery for the presbyopic age group, said Francesco Carones, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

"Refractive lens exchange may be considered the procedure of choice for correcting high ametropia in the presbyopic age group because it provides immediate stable results with negligible side effects," said Dr. Carones, medical director, Carones Ophthalmology Center, Milan, Italy. "While previous studies evaluating refractive lens exchange using various multifocal and accommodative IOLs have yielded variable results, our experience with the apodized diffractive ReSTOR IOL shows it is associated with a full range of good uncorrected vision and high patient satisfaction.

"This is just early follow-up from a small series, but perhaps refractive lens exchange with the ReSTOR IOL may become the ultimate surgery for presbyopic patients to avoid any problems from future development of cataract," he added. Dr. Carones' approach is considered an off-label use in the United States.

Dr. Carones evaluated outcomes associated with RLE using the ReSTOR IOL in a prospective, consecutive, interventional case series study enrolling 15 patients who underwent bilateral surgery. The group consisted of 12 hyperopic patients (1.25 to 3.25 D) and three myopic patients (–1.25 to –3.75 D). The patients ranged in age from 44 to 65 years old and none had any evidence of cataract.

Eligibility criteria for the procedure required that the patients have <1 D of astigmatism, be highly motivated to achieve spectacle independence, and to be defocus correctable using an IOL with power ranging from 18 to 25 D.

The procedure was performed through a 2.8-mm clear corneal temporal tunnel incision and with creation of a 5-mm capsulorhexis. The IOL was implanted using the Monarch C cartridge (Alcon) and the Royale injector (ASICO). A suture was placed for astigmatic control only in eyes with >0.50 D with-the-rule astigmatism.

Outcomes were evaluated at 1, 3, and 6 months after surgery and included measurements of manifest refraction, uncorrected and best spectacle-corrected visual acuity (BSCVA) at distance (4 m), intermediate (60 cm), and near (35 cm). Dr. Carones also performed wavefront analysis for a 6-mm pupil size using the LADARWave aberrometer (Alcon), and administered a psychometric evaluation to determine patient satisfaction.

Visual results At 6 months, all patients had SE ±0.62 D, distance uncorrected visual acuity (UCVA) 20/25 or better, and near UCVA J2 or better. Ten (67%) patients achieved intermediate UCVA of J2 or better, and in 14 (93%) patients, intermediate UCVA was J3 or better.

"The one patient with poorer intermediate vision was a PC user and relied on spectacle correction to work at the computer," Dr. Carones said.

Safety was very favorable. At 6 months, BSCVA was 20/20 or better in all eyes with none experiencing any loss from their preoperative level. No patients were experiencing any visual symptoms in bright light conditions or any vision-impairing symptoms in dim light conditions, although two patients were slightly bothered by a ring pattern when fixating on lights.

"At 1 month, seven patients had slight visual symptoms in dim light conditions, but by 3 months, only four patients were bothered, and the patients who still are experiencing symptoms at 6 months note they have improved with time," Dr. Carones said. "Probably patients go through a kind of brain-process-training period during which the second, out-of-focus image gets suppressed."

The wavefront testing showing that compared with preoperative values, there were slight increases in RMS values for higher-order aberrations and coma, while spherical aberration was reduced. However, none of the changes was statistically significant.