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Search / Trial NCT06257914

Aberrometry and Straylight Measurements as an Indication for Cataract Surgery

Launched by AMPHIA HOSPITAL · Feb 6, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Aberrometry Straylight Prom Cataract Indication For Cataract Surgery

ClinConnect Summary

Cataracts are a clouding of the lens of the eye. The symptoms of cataracts depend on where the clouding is in the lens and how extensive it is. Symptoms that patients may experience are blurred vision, poor vision at night, double vision in one eye, glare from backlight (such as from car headlights or a low sun), dulling of colours and a rapid change in refractive error. It is the most common cause of low vision in the world. Treatment for cataracts is surgical replacement of the cloudy lens for a clear artificial lens. The indication for cataract surgery is currently based on the visual im...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • At least 18 years old,
  • Diagnosis of cataract in both eyes,
  • Based on informed consent, will undergo cataract surgery in both eyes (not necessarily immediately bilateral),
  • Expected best-corrected visual acuity ≥ 0.7 in both eyes,
  • Pupil diameter in mydriasis ≥4 mm and
  • Implantation of a (standard) monofocal, toric monofocal or (non)toric Extended Depth of Focus artificial lens.
  • Exclusion Criteria:
  • Insufficient understanding of the Dutch language to comply with study procedures,
  • Spherical refraction of ≤-15 dioptres (due to impossibility of measurement with aberrometer),
  • Corneal astigmatism of ≥3 dioptres (because of possible effect on reliability of straylight measurement),
  • Implantation of a multifocal artificial lens (because the aberrometer \[still\] cannot properly determine the optical quality of this type of artificial lens),
  • Cataract surgery of the second eye not performed 3 months after surgery of the first eye,
  • Comorbidity (other than cataract) that may significantly affect vision or give prolonged duration of vision recovery, such as Fuchs\' endothelial cell dystrophy, significant macular degeneration, glaucoma, diabetic maculo- or retinopathy, or an experienced cerebral vascular accident,
  • A history of eye surgery (such as corneal refractive surgery and phakic lens implantation),
  • An increased risk of complicated cataract surgery, such as lens (sub)luxation, brunescent cataract, posterior polar cataract and a history of trauma to the eye,
  • Unable to be reliably measured with aberrometer or straylight meter, and
  • A peroperative or postoperative complication that significantly affects vision and has not recovered within 3 months of surgery.

About Amphia Hospital

Amphia Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong commitment to excellence in patient care, Amphia Hospital combines state-of-the-art facilities with a multidisciplinary team of experienced healthcare professionals. The hospital's clinical trial program focuses on a wide range of therapeutic areas, fostering collaboration with researchers and industry partners to develop new treatment options. Amphia Hospital aims to contribute to the global body of medical knowledge while ensuring the highest ethical standards and patient safety throughout the research process.

Locations

Breda, Noord Brabant, Netherlands

Patients applied

0 patients applied

Trial Officials

Nic J Reus, MD, PhD

Principal Investigator

Amphia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported