Large Study Supports Refractive Procedure, Implant for Presbyopia

Bilateral refractive lens exchange with a trifocal intraocular lens (IOL) appears to be a safe and effective treatment modality for patients with presbyopia, according to the results of a study published in The British Journal of Ophthalmology.

To evaluate the safety and effectiveness of bilateral refractive lens exchange with trifocal IOL implantation, the investigators conducted a multicenter retrospective interventional case series of 17,603 consecutive patients who underwent the procedure between 2013 and 2019.

The main outcomes of the study were postoperative manifest refraction spherical equivalent (MRSE), uncorrected distance (UDVA) and near (UNVA) visual acuity, corrected distance visual acuity (CDVA), vision gain/loss, safety index (postoperative CDVA/preoperative CDVA), and efficacy index (postoperative UDVA/preoperative CDVA), IOL power calculation accuracy, and rate of excimer laser enhancements.

The study included 35,206 eyes of 17,603 patients (52.7% men and 47.3% women), with a mean age of 54.8 years (range, 45-80). Preoperatively, the patients had a mean MRSE of +0.15 ± 2.50 diopters (D; range, -14.88 to +8.50) and mean CDVA (logMAR) of -0.03 ± 0.06 (range, 0.10 to -0.20).

At 3 months postoperatively, patients had a mean MRSE of 0.00 ± 0.40 D, mean binocular UDVA of −0.03 ± 0.09, and 82.2% of patients had combined binocular UDVA and UNVA equal or better than 0.00 and Jaeger 3. The investigators found that approximately 86% of the eyes were within 0.50 D of MRSE. 

At 6 months postoperatively, 16.5% of patients had received enhancement surgery, and of these surgeries, 96.7% employed the femto-LASIK technique. The investigators determined that the IOL power calculation refining, which was evaluated yearly, improved accuracy and reduced the enhancements rate from 20% in 2013 to 12% in 2019. 

Following surgery, the safety and efficacy indices were 0.98 ± 0.11 and 0.85 ± 0.18, respectively; 90.13% of the eyes had no change in CDVA, 2.69% gained 1 line, 5.86% lost 1 line and 0.38% had lost 2 or more lines of CDVA, with cystoid macular oedema (n = 53) and posterior capsular opacification (n = 35) as the main causes. After proper care of the treatable causes of vision loss (78.5%), the mean CDVA of the eyes with loss of two or more lines of CDVA improved from 0.20 ± 0.05 to 0.04 ± 0.06. The final incidence of two or more lines of CDVA was 0.08%.

“[B]ilateral presbyopic [refractive lens exchange] with trifocal IOLs is a safe and effective modality of treatment for patients with dysfunctional lens syndrome and presbyopia,” the researchers report. “Refractive enhancements should be considered as part of the treatment, and its rate should be explained to the patient before surgery.”

Limitations of the study included use of a reading chart deemed for clinical purposes only and lack of routine intermediate distance vision measurements.

Reference

Brenner LF, Nistad K, Schonbeck U. Rethinking presbyopia: results of bilateral refractive lens exchange with trifocal intraocular lenses in 17,603 patients. Br J Ophthalmol. Published online February 2, 2022. doi:10.1136/bjophthalmol-2021-319732