ICL and LASIK for Hyperopic Astigmatism

NCT ID: NCT06742541

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-03-01

Brief Summary

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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

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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.

Conditions

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Astigmatism Hyperopia

Keywords

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ICL LASIK Hyperopia Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Planned surgery to receive a spherical Implantable Collamer Lens (ICL) followed by a planned adjunctive LASIK postoperatively

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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ICL + LASIK

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University

OTHER

Sponsor Role lead

Responsible Party

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Daniel Li

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avi Wallerstein, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

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Vision Group Canada

Montreal, , Canada

Site Status

Countries

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Canada

References

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Li DQ, Gauvin M, Rocha G, Trottier P, Racine L, Wallerstein A. Spherical implantable collamer lens with postoperative adjunctive LASIK in the treatment of high compound hyperopic astigmatism. BMC Ophthalmol. 2025 Jan 24;25(1):44. doi: 10.1186/s12886-024-03828-5.

Reference Type DERIVED
PMID: 39856569 (View on PubMed)

Other Identifiers

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VGC81

Identifier Type: -

Identifier Source: org_study_id