ICL and LASIK for Hyperopic Astigmatism

McGill University

Status and phase: Completed; Early Phase 1

Conditions: Astigmatism; Hyperopia

Treatments: Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively

Study type: Interventional

Funder types: Other

Identifiers

NCT06742541

VGC81

Details and patient eligibility

About

This study investigates a two-step treatment for people with severe farsightedness combined with astigmatism. The first step involves implanting a specially designed lens inside the eye (a spherical Implantable Collamer Lens, or ICL) to improve vision. Later, a laser procedure (LASIK) is performed to fine-tune the results for even better clarity.

Full description

To assess refractive and visual outcomes of a spherical Implantable Collamer Lens (ICL) followed by planned postoperative adjunctive laser-assisted in situ keratomileusis (LASIK) in the treatment of high compound hyperopic astigmatism. In this prospective, multi-center, multi-surgeon, single-arm study, eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism underwent surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively. Outcomes measures included postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, spherical (SEQ) and defocus equivalent (DEQ), efficacy index, safety index, and astigmatism vector analyses.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preoperative hyperopic sphere of ≥+3.50 D
• Astigmatism of ≥+2.00 D
• Stable refraction for the previous 12 months
• Age older or equal to 18 years
• Anterior chamber depth (ACD) from corneal endothelium to anterior lens capsule of 3.0 mm or greater

Exclusion criteria

• Age younger than 18 years
• Patients lost to follow-up
• Cataract formation
• History of glaucoma or retinal detachment
• Macular degeneration
• Diabetic retinopathy
• History of ocular inflammation
• Signifcant irregular corneal topography
• Evidence of inconsistent imaging from dry eyes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Patients with high compound hyperopic astigmatism

Experimental group

Description:

eyes with ≥3.50 D hyperopia and ≥2.00 D of astigmatism undergoing planned surgery receiving a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively

Treatment:

Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively