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Completed

NCT Number: NCT04443231

Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

To observe the retinal microvascular alteration during 3 months follow-up after Implantable Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical coherence tomography angiography (OCTA) analysis.

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Key information

Conditions

Adolescent Adult Eye Diseases Female Follow-Up Studies Human Lens Implantation, Intraocular Male Myopia Phakic Intraocular Lenses Postoperative Period Preoperative Period Prospective Studies Refractive Errors Retinal Vessels Tomography, Optical Coherence

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was used to image the superficial and deep retinal vascular plexuses before ICL implantation surgery and at 3 months follow-up. OCTA images were corrected for magnification, skeletonized, separated the large vessels and partitioned. Retinal microvascular density was measured by using fractal dimension analysis. The aim of this study was to uncover potential retinal vascular network alterations induced by ICL implantation surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 to 45 years old;
  • Binocular myopia, with a refraction of greater than -3 diopters (D);
  • anterior chamber depth (ACD, measured from the endothelium to the crystalline lens) > 2.8 mm;
  • corneal endothelial cell count (cECC) ≥ 2000 cells/mm2;
  • stable refraction at least 1 year before surgery;
  • unsatisfactory vision with contact lenses or spectacles.

Exclusion criteria

  • history of intraocular surgery
  • other ocular pathology (uveitis, glaucoma, cataract, keratoconus, severe dry eye, etc.)
  • other serious systemic disease (diabetes, uncontrolled hypertension, severe hyperthyroidism, etc.).

Treatment and study plan

Optical coherence tomography angiography

Device

AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.

Primary outcomes

  1. Retinal microvessels density

    Time frame: 3 months postoperatively

    Retinal microvessels density was measured with fractal dimension analysis by using Matalb (The Mathworks, Inc., Natick, MA, USA)

Secondary outcomes

  1. Best corrected visual acuity

    Time frame: 3 months postoperatively

    BCVA was evaluated by decimal Snellen and converted to the logarithm of the minimum angle of resolution (logMAR) for statistical analysis.

  2. Mean refractive spherical equivalent

    Time frame: 3 months postoperatively

    MRSE = Spherical power + 0.5 * Cylindrical power

  3. Intraocular pressure

    Time frame: 3 months postoperatively

    The IOP was measured using a non-contact tonometer (CT-80; Topcon, Tokyo, Japan).

  4. Vault

    Time frame: 3 months postoperatively

    The central vault of the ICL (distance from posterior surface of ICL to the crystalline lens) was measured using Optical Coherence Tomography (Visante; Carl Zeiss Meditec, Jena, Germany)

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2020
Registry last updated
Jun 23, 2020

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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