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Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation

P

Peking University

Status

Completed

Conditions

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

Treatments

Device: Optical Coherence Tomography Angiography

Study type

Observational

Funder types

Other

Identifiers

NCT04443231
tch0101

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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