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Completed

NCT Number: NCT06742541

ICL and LASIK for 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.

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Key information

Conditions

Astigmatism Eye Diseases Hyperopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Vision Group Canada

Montreal, H3B 4W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Other names: ICL + LASIK

Primary outcomes

  1. Post-operative visual acuitiy

    Time frame: 90 days after lasik surgery

    postoperative uncorrected (UDVA) and corrected distance visual acuity (CDVA)

Secondary outcomes

  1. Manifest refraction

    Time frame: 90 days after lasik surgery

    The refraction (glasses prescription required) done manually of the operated eye

  2. Spherical (SEQ) and defocus equivalent (DEQ)

    Time frame: 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

  3. Efficacy Index and Safety Index

    Time frame: 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

  4. Astigmatism Vector Analysis

    Time frame: 90 days after LASIK surgery

    The residual astigmatism left after surgery, representing the deviation from the intended correction.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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