Aberrometry and Straylight Measurements as an Indication for Cataract Surgery

NCT06257914 | Enrolling By Invitation

• 1 other identifier: N2024-0666
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cataracts are a clouding of the lens of the eye. Cataract surgery replaces the cloudy lens with a clear artificial lens. It is one of the leading causes of low vision worldwide. Since cataracts are mostly age-related, the number of patients with cataracts is increasing sharply due to an ageing population. The indication for cataract surgery is currently based on the visual impairment experienced by the patient, a measurement of visual acuity and the ophthalmologist's assessment of the extent to which the clouding of the lens explains the patient's symptoms. It has been said that after cataract surgery, "the world opens up to you". However, about 10% of patients actually experience worse vision after surgery. This amounts to almost a whole month of potentially unnecessary surgery. It is therefore important to develop a more objective indicator for cataract surgery. Our study focuses on measuring the optical quality of the eye before and after cataract surgery. The investigators also ask patients before and after cataract surgery how patients themselves perceive the quality of their vision. The investigators do this with different patient-reported outcomes. The investigators investigate whether the objective measurement of the optical quality of the eye can predict which patients will be satisfied with the cataract surgery. With this, the investigators aim to further improve patient care and prevent unnecessary surgery.

Conditions

Cataracts; Cataract Surgery

Keywords

aberrometry; straylight; PROM; cataract; indication for cataract surgery

Outcome Measures

Primary Outcomes (4)

• log(VSX)

  preoperative aberrometry measurements, expressed as log(VSX)

  From enrollment to one year after cataract surgery

• log(s)

  preoperative straylight measurements, expressed as log(s)

  From enrollment to one year after cataract surgery

• preoperative Catquest-9SF score (expressed as Rasch score)

  preoperative Catquest-9SF score, expressed as Rasch score

  From enrollment to one year after cataract surgery

• postoperative Catquest-9SF score (expressed as Rasch score)

  postoperative Catquest-9SF score, expressed as Rasch score

  From enrollment to one year after cataract surgery

Study Arms (1)

Cataract

Patients with cataract in both eyes

Diagnostic Test: Catquest-9SF

Interventions

Catquest-9SF DIAGNOSTIC_TEST

Measurement of self-assessed visual function with Catquest-9SF, measurement of ocular aberrations with iTrace (Tracey Technologies), and straylight measurements with C-Quant (Oculus)

Also known as: Aberrometry (iTrace), Straylight measurement (C-Quant)

Cataract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ophthalmic patients with cataracts in both eyes seeking surgery on them

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amphia Hospital: lead

Study Sites (1)

Amphia

Breda, North Brabant, 4818 CK, Netherlands

Location

MeSH Terms

Conditions

Cataract

Interventions

Aberrometry

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nic J Reus, MD, PhD

  Amphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: May 6, 2024
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)