臨床研究等提出・公開システム

An Investigator-initiated trial to assess a long-term safety and efficacy of scleral lens (AL-01) in subjects with corneal astigmatism enrolled in the previous SLICK study (SLICK-extension)

Long-term extension study of scleral lens (AL-01) in subjects with corneal astigmatism

Hiraoka Takahiro

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba-shi, Ibaraki, 305-8576, Japan

thiraoka@md.tsukuba.ac.jp

Wakamatsu Akira

University of Tsukuba

2-1-1, Amakubo, Tsukuba-shi, Ibaraki, 305-8576, Japan

+81-29-853-3326

slick_office@md.tsukuba.ac.jp

Recruiting

Aug. 04, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Signed informed consent must be obtained prior to participation in the study.
2) Subjects who have completed the protocol-specified observations in the previous study of AL-01.
3) Subjects for whom the investigator expects continued clinical benefit from wearing AL-01.

1) Subjects with acute or subacute inflammation or infection in the study eye
2) Subjects with uveitis in the study eye
3) Subjects with a history of corneal transplant in the study eye
4) Pregnant, in postpartum or intends to become pregnant within the study period
5) Subjects with corneal opacity and which have no potential for vision improvement with corrective lenses
6) Subjects with intermediate media opacities (e.g., moderate to severe cataract or vitreous opacities) or obvious retinal diseases, and which cause vision impairment
7) Subjects with ocular complications of Stevens-Johnson syndrome or toxic epidermal necrolysis

Both

corneal astigmatism

AL-01 (scleral contact lens)

Safety (e.g., Adverse events, Serious AEs) of AL-01

- Changes from baseline in corneal endothelial cell density and morphology
- Changes from baseline in corneal tomographic parameters
- Changes from baseline in BCVA with AL-01 alone, AL-01 and spectacle
- Proportion of participants achieving BCVA improvement of 0.2 logMAR or greate
- Changes from baseline in contrast sensitivity at four spatial frequencies and AULCSF (area under the log contrast sensitivity function)
- Changes from baseline in Pain-VAS and NEI VFQ-25 scores

+81-29-853-3914

July. 14, 2026

No

none