Samsara Vision reported intermediate-term visual and safety outcomes of the SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) in patients 6 months post-surgery. Overall, researchers found that SING IMT implantation improved distance and near vision, with a low impact on the corneal endothelium cell density and manageable safety outcomes, the company said in a press release. These positive results were also recently published in the journal Heliyon.

Researchers reported that at 6 months post-surgery, at least 1-, 2-, and 3-line gains in best-corrected distance visual acuity (BCDVA) were achieved in 97.1%, 68.6% and 51.4% of operated eyes, respectively (n=35), with the mean ± standard deviation (SD) change in BCDVA from baseline - 0.29 ± 0.142. The percentage of patients able to read at near distance increased from 28.6% at baseline to 97.1% at 6 months. In addition to distance vision, the study also found that corrected near visual acuity was also significantly improved by ⁓3 lines at 6 months post-surgery.

Approved for use in CE Mark referenced countries, the retrospective SING IMT study included 35 patients (55 years or older) with late-stage AMD, treated at either the University Federico II in Naples, Italy or the Policlinico Gemelli hospital in Rome. To optimize the visual outcomes, patients participated in a required rehabilitation program starting 6 weeks after surgery, attending eight 90-minute sessions every 2-to-3 weeks for 6 months. The program included exercises to strengthen skills such as visual abilities, reading, writing, visual motor integration and mobility.

Notably, there was no clinically meaningful change from baseline in IOP or anterior chamber depth and the mean (SD) change from baseline in corneal endothelial cell density (ECD) at 6 months in operated eyes was -280.7 (315.9) cells/mm2 (-11.4 %). Importantly, no new complications occurred between the 3- and 6-month follow-ups. Most expected adverse events, such as corneal edema (22.9%), resolved by 6 months with the use of topical medications, while some device-related events (eg, iris damage, pigment deposits) persisted, indicating an acceptable safety profile for SING IMT implantation, the company said in the press release. 

"This 6-month review highlights the potential of SING IMT to restore meaningful vision to individuals blinded by AMD, while preserving long-term corneal health with its innovative design," said Prof. Toro, co-author of the study from University Hospital Federico II.

Study co-author Prof. Savastano, Regional Hospital “F. Miulli”, Acquaviva delle Fonti (BA), Italy, added, "We will continue monitoring these patients to ensure their improved vision translates into a better quality of life and enhanced daily functioning.”

According to Samsara Vision, among several studies published in 2024, an especially pertinent one was a small retrospective study (n=11) published in Ophthalmology and Therapy that evaluated functional vision approvements following SING IMT implantation. The company said the study reported significant improvement in real-world tasks such as reading, writing, visual motor integration and mobility, a key predictor of patient-reported visual ability and vision-related quality of life.

The SING IMT is an intraocular telescope approved for use in patients without previous cataract surgery and age 55 years and older in CE Referenced countries and is under investigation in the United States, the company said in the press release. 

The company also noted that the SING IMT does not return vision to the level a patient had before AMD, nor will it completely make up for vision loss. Driving is contraindicated with the device. The most common risks of the SING IMT surgery include inflammatory deposits or precipitates on the device and increased IOP. Adverse events in the recent study include corneal edema, and one patient had a decrease in visual acuity. The company said that there is also a risk that having the telescope implantation surgery could worsen vision rather than improve it, and that individual results may vary.