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An Investigator-initiated, multicenter, single-arm, open-label study of scleral lens (AL-01) in perticipants with corneal astigmatism inadequate correction to spectacles or existing contact lens (SLICK)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	corneal astigmatism
Date of first enrollment	17/04/2026
Target sample size	25
Countries of recruitment
Study type	Interventional
Intervention(s)	Subjects wear the investigational device (AL-01) for 13 weeks.

Outcome(s)

Primary Outcome

Change from baseline in ETDRS BCVA with investigational device (AL-01) at week 13

Secondary Outcome

- Changes from baseline in contrast sensitivity at four spatial frequencies and AULCSF (area under the log contrast sensitivity function) - Changes from baseline in ETDRS BCVA with AL-01 alone, AL-01 and spectacle - Proportion of participants achieving BCVA improvement of 0.2 logMAR or greater at week 13 - Changes from baseline in corneal tomographic parameters and higher-order wavefront aberration at week 13 - Changes from baseline in pain-VAS and NEI VFQ-25 scores - Changes from baseline in corneal endothelial cell density and morphology - safety (e.g., Adverse events, Serious AEs) and tolerability of AL-01

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Signed informed consent must be obtained prior to participation in the study. 2) Subjects are aged 18 and over at informed consent. 3) Subjects with corneal astigmatism, in the study eye, who are unable to achieve best contact lens-corrected visual acuity of 0.7 or more, or who are intolerant to contact lenses. 4) Decimal best spectacle-corrected visual acuity must be less than 0.7 and 0.01 or more in the study eye at eligibility screening. 5) Subjects who are able to discontinue hard contact lens wear for at least 2 weeks, or soft contact lens wear for at least 1 week, in the study eye prior to the eligibility screening.
Exclude criteria	1) Allergy to any gas-permeable contact lens or contactlens care products. 2) Acute or subacute inflammation or infection in the study eye. 3) Uveitis in the study eye. 4) History of Keratoplasty in the study eye. 5) Pregnant, in postpartum or intends to become pregnant within the study period. 6) Subjects with corneal opacity and which in the Investigator's opinion have no potential for vision improvement with corrective lens. 7) Subjects with intermediate media opacities (e.g., moderate to severe cataract or vitreous opacities) or obvious retinal diseases, and which cause vision impairment. 8) Ocular complications of Stevens-Johnson syndrome or toxic epidermal necrolysis. 9) Inability to insert and remove investigational device, or wear it daily.