Purpose of the Study: The purpose of the study was to investigate results of selective laser trabeculoplasty (SLT) performed directly on the sclera without a gonioscopy lens.
Design: Interventional case series, prospective, randomized, masked, controlled clinical trial.
Methods: Setting: Meir Medical Center, Kfar-Saba, Israel. Study population: Adults with uncontrolled primary open angle or pseudoexfoliation glaucoma randomized into 2 groups. Intervention: The controls underwent conventional SLT with 100 spots delivered using a gonioscopy lens for 360 degrees of the trabecular meshwork. The study group underwent irradiation using the same parameters with the laser applications administered on the perilimbal sclera. Study visits: 1 hour, 1, 7, 30, 60, 180, and 365 days postprocedure. Main Outcome Measures: Intraocular pressure (IOP) and side effects.
Results: Thirty adults were randomized into 2 groups. The mean (±SD) pretreatment IOP was 20.21±3.19 mm Hg for the study group (n=14) and 21.14±2.98 mm Hg for the controls (n=14; P =0.43), dropping to 15.50±3.77 and 15.00±4.08 mm Hg (P =0.74) after 6 months and to 16.00±3.31 and 14.00±2.45 mm Hg (P =0.22) after 12 months. The average IOP reduction after 6 and 12 months was 23.4% and 20.83% for the study group and 27.1% and 33.77% for the controls (P=0.528). Success (a decrease of ≥15% at 6 months with no additional medications, laser, or glaucoma surgery) was achieved in 12 (85.7%) study patients and 9 (69.2%) controls (P=0.385). Complications were mild and transient (n=30), although significantly higher in the controls (n=15; P <0.0001).
Conclusions: SLT applied directly to the perilimbal sclera may be as efficacious as the conventional procedure for 1 year.
*Department of Ophthalmology, Meir Medical Center, Kfar Saba
§Department of Ophthalmology, Assaf Harofeh Medical Center
†Sackler Faculty of Medicine, Tel Aviv University
‡The Ein Tal Medical Center, Tel-Aviv
∥Department of Ophthalmology, Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer, Israel
Supported in part by a grant from the Clair and Amedee Martier Institute for the Study of Blindness and Visual Disorders, Tel-Aviv University.
N.G., S.O., and M.B.: Conception, design, analysis, writing. N.G., E.I.A., and M.B.: critical revision and final approval. N.G., S.O., A.B., F.S., and Y.B.: data collection. N.G., Y.B., A.K.M., and E.I.A.: materials and patient recruitment. N.G., S.O., and M.B.: literature search.
Disclosure: M. B. is actively pursuing commercial development of transscleral LTP. The remaining authors declare no conflict of interest.
Reprints: Noa Geffen, MD, Department of Ophthalmology, Meir Medical Center, Tchernihovsky 45 Street, PO Box 44100, Kfar Saba, 472130, Israel (e-mail: firstname.lastname@example.org).
Received September 19, 2015
Accepted May 12, 2016