ICL and LASIK for Hyperopic Astigmatism

Early Phase 1

Completed

• Conditions: Astigmatism; Hyperopia

• Registration Number: NCT06742541
• Lead Sponsor: McGill University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-operative visual acuitiy	90 days after lasik surgery	postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)

Secondary Outcome Measures

Name	Time	Method
Manifest refraction	90 days after lasik surgery	The refraction (glasses prescription required) done manually of the operated eye
Spherical (SEQ) and defocus equivalent (DEQ)	90 days after LASIK surgery	SEQ: a single value used to describe a refractive error, combining the spherical and cylindrical components of a prescription DEQ: quantifies the overall refractive blur from spherical and cylindrical components
Efficacy Index and Safety Index	90 days after LASIK surgery	Efficacy Index: ratio of postoperative uncorrected distance visual acuity (UDVA) to preoperative corrected distance visual acuity (CDVA) Safety Index: ratio of postoperative corrected distance visual acuity (CDVA) to the preoperative CDVA
Astigmatism Vector Analysis	90 days after LASIK surgery	The residual astigmatism left after surgery, representing the deviation from the intended correction.

Trial Locations

Locations (1)

Vision Group Canada; 🇨🇦 Montreal, Canada