ICL and LASIK for Hyperopic Astigmatism

Spherical Implantable Collamer Lens With Postoperative Adjunctive LASIK in the Treatment of High Compound Hyperopic Astigmatism

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Hyperopia
• Intervention / Treatment: Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada, H3B 4W8
    • Vision Group Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with high compound hyperopic astigmatism; 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	Device: Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively; Planned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively; Other Names: ICL + LASIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative visual acuitiy	postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)	90 days after lasik surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manifest refraction	The refraction (glasses prescription required) done manually of the operated eye	90 days after lasik surgery
Spherical (SEQ) and defocus equivalent (DEQ)	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	90 days after LASIK surgery
Efficacy Index and Safety Index	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	90 days after LASIK surgery
Astigmatism Vector Analysis	The residual astigmatism left after surgery, representing the deviation from the intended correction.	90 days after LASIK surgery

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Avi Wallerstein, MD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Hyperopia; Astigmatism; LASIK; ICL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: VGC81

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Small study of only 32 patients, individual data will not be shared to protect patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes