Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07276217

Phacoemulsification and Intraocular Lens Implantation: Patient Registry

The aim of the study is to create a patient registry that will allow for comparison of cataract treatment outcomes using phacoemulsification with implantation of different types of intraocular lenses.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cataract Eye Diseases Intraocular Lens Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This study will establish a registry to evaluate outcomes associated with intraocular lens implants in patients undergoing cataract surgery. Retrospective assessments will include routinely collected preoperative, intraoperative, and postoperative data. Prospectively, visual acuity, refraction, examination findings, patient-reported outcomes, and complications will be collected for up to 60 months after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have undergone cataract surgery or are scheduled for bilateral cataract surgery with implantation of an extended-depth-of-focus (EDOF) intraocular lens, a monofocal-plus intraocular lens, or a standard monofocal intraocular lens.

Exclusion criteria

  • Anterior or posterior segment pathologies affecting postoperative visual acuity, including but not limited to: severe dry eye syndrome, corneal dystrophies, uveitis, retinal degenerative changes, glaucoma, or diabetic retinopathy.
  • Pseudoexfoliation syndrome
  • Keratoconus
  • History of laser refractive surgery
  • Prior ocular surgery other than cataract surgery
  • Amblyopia
  • Posterior capsule opacification
  • Postoperative best-corrected visual acuity (BCVA) less 0.5
  • Intraoperative complications, including posterior capsule rupture

Treatment and study plan

Intraocular lens

Device

Implantation of an intraocular lens following phacoemulsification cataract extraction, with lens type selected according to routine clinical practice (e.g., monofocal, toric, multifocal, or extended-depth-of-focus).

Primary outcomes

  1. Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Distance, intermediate, and near visual acuity will be measured both uncorrected and corrected using standard ETDRS charts at 4 meters for distance, 66 cm for intermediate, and 40 cm for near visual acuity.

Secondary outcomes

  1. Objective Refraction

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Spherical and cylindrical refractive errors will be measured objectively using an autorefractometer.

  2. Subjective Refraction

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Spherical and cylindrical refractive errors will be measured subjectively using trial frame glasses and patient responses.

  3. Monocular and Binocular Defocus Curve

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Visual acuity will be measured at varying defocus levels under monocular and binocular conditions to assess the range of functional vision. Measurements will be taken in 0.5 D steps from +1.00 D to -2.50 D.

  4. Contrast Sensitivity

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Contrast sensitivity will be assessed using the Matrix Perceptix test under photopic light conditions.

  5. Keratometry

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Keratometry will be measured using IOLMaster 500 and Pentacam

  6. Anterior Chamber Depth

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Anterior chamber depth will be measured using IOLMaster 500 and Pentacam.

  7. Pupil Size

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Pupil diameter will be measured using IOLMaster 500 and Pentacam.

  8. Central Corneal Thickness

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Central corneal thickness will be measured using Pentacam.

  9. Anterior Chamber Angle

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Anterior chamber angle will be measured using Pentacam.

  10. Primary and Secondary Spherical Aberrations

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Primary and secondary spherical aberrations will be measured using Pentacam.

  11. Patient-Reported Spectacle Independence

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Degree of spectacle independence will be assessed using the Patient-Reported Spectacle Independence Questionnaire (PRSIQ).

  12. Patient-Reported Quality of Vision

    Time frame: Measured at the follow-up visit up to 60 months after cataract surgery

    Quality of vision will be assessed using the Quality of Vision Questionnaire (QoV).

Sponsors and collaborators

Lead sponsor

Sensor Cliniq

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.