Scleral implant procedure effective in restoring near vision for presbyopia

Take-Home

A scleral spacing procedure for the treatment of presbyopia restored near vision in presbyopic emmetropic patients without adverse effects.

By Lynda Charters; Reviewed by Michael Endl, MD

Amherst, NY-A procedure using scleral implants (Refocus Scleral Implants, Refocus Group) for the treatment of presbyopia achieved a substantial improvement in near visual acuity 2 years after surgery in a single-center study-with 96% of patients having 20/40 or better monocular vision and all patients achieving 20/40 or better binocular vision.

“In our experience, the scleral spacing procedure was effective for restoring near visual acuity in presbyopic emmetropic patients without adverse effects both objectively and subjectively,” said Dr. Michael Endl, MD, who is in private practice in Amherst, NY, and principal investigator of this study. “The improvement in vision increased and has been maintained over the course of the 2-year clinical trial.”

Dr. Endl highlighted a number of procedures that are available for treating presbyopia.

·      Corneal approaches include excimer laser (multifocal, monovision), femtosecond laser (intrastromal rings), conductive keratoplasty, and corneal inlays.

·      Presbyopic correction using IOLs includes monofocal (monovision), multifocal, and accommodating approaches.

·      Scleral surgeries include the scleral implant procedure and scleral laser incisions.

Single-center experience

Dr. Endl and Claus Fichte, MD, evaluated the effect of the scleral implants on distance-corrected near visual acuity (DCNVA) after implantation at the center with the longest follow-up in a multicenter, prospective, IDE clinical trial.

Sixty-three eyes of 33 patients (20 men, 13 women) underwent this procedure at Fichte, Endl and Elmer Eyecare. The average patient age at surgery was 54 years (range, 50 to 60 years). The average manifest refraction spherical equivalent (MRSE) was +0.17 D (range, –0.50 to +0.875 D).

During the scleral spacing procedure, four scleral implants were circumferentially implanted intrasclerally in the oblique quadrants just posterior to the lens equator. Inclusion criteria included best-corrected distance visual acuity (BCDVA) of 20/20 in each eye, MRSE between +0.75 to –0.50 D with 1 D or less of astigmatism and DCNVA between 20/50 to 20/100. All eyes were phakic.

The primary outcome of DCNVA was obtained using standardized illumination at 40 cm at all visits. Patients with scleral thickness less than 530 µm and those who had undergone a previous ocular surgery or chronic ocular disease were excluded.

Patient enrollment and the surgeries were completed in August 2012. Two-year data are available for 25 patients.

Visual acuity outcomes

By month 24 after the scleral implant procedure, 96% of patients achieved DCNVA of 20/40 or better monocularly and three lines of improvement in DCNVA compared with baseline, Dr. Endl noted.

All patients achieved DCNVA or 20/40 or better binocularly. The distribution of binocular DCNVA at 2 years was 100% 20/40; 95% 20/32; 64% 20/25, and 27% 20/20. The investigators found that visual acuity improved over the course of the 2-year follow-up period.

There were minimal adverse events postoperatively and all study-related adverse events resolved without sequelae. No patients lost BCDVA.

Michael Endl, MD

E: mpderme@aol.com

The article was adapted from a presentation at the 2014 meeting of the American Society of Cataract and Refractive Surgery. Dr. Endl has no financial interest in the subject matter. Refocus Group provided research funding and travel expenses.