Pilot Study Of Sphere And Toric Phakic Implantable Collamer Lenses To Correct Or Reduce Myopia With Presbyopia With Or Without Astigmatism

To evaluate the clinical performance of the investigational Toric and Sphere Implantable Collamer^® Lens with Aspheric (EDOF) Optic to correct or reduce myopia with presbyopia with or without astigmatism.

This study was conducted at Asian Eye Institute in Makati City, Philippines under the oversight of Principal Investigator Robert Ang, MD.

This exploratory prospective, open-label trial of a Toric EDOF ICL is conducted at one site in the Philippines. Up to 90 eyes in up to 50 phakic subjects with stable refraction will be implanted bilaterally with toric (TEDOF, +1.0 D to 3.0 D cyl power) and/or spherical (EDOF) ICLs. Patients with sight threatening diseases or a history of ocular surgery are excluded.

Subjects are followed-up for 6 months after surgery. Outcomes include adverse events (AE) and performance parameters such as uncorrected distance, intermediate and near visual acuity (UDVA, UIVA, UNVA), manifest refraction spherical equivalent (MRSE), astigmatism correction and subjective visual quality

Six-month data of  34 eyes with toric EDOF ICL and 10 eyes with spheric EDOF ICL show monocular uncorrected mean VAs of 0.05 ± 0.08 (TEDOF) and 0.08 ± 0.08 (EDOF) logMAR for distance (UDVA), 0.03 ± 0.10 and 0.06 ± 0.09 logMAR for intermediate (UIVA) and 0.15±0.12 and 0.10±0.13 logMAR for near vision (UNVA). Post-operative MRSE is 0.08±0.36D and 0.04±0.33D logMAR, respectively. At the 6 Month Visit, subjects reported satisfaction with their vision at all distances and overall.

Interim analysis of toric and spherical EDOF ICL treated eyes through 6 months of follow-up shows promising results in terms of refractive correction and visual acuity at all distances.  Patient satisfaction results support the good performance of both lenses.