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OpenTrials
Completed

NCT Number: NCT05427526

Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.

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Key information

Conditions

Vitreous Disorder Cataract Eye Diseases Lens Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.

  • Visual quality: CatQuest questionnaire
  • Near vision: NAVS questionnaire
  • Glare: APPLES questionnaire

These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients that had a LARA IOL implanted in combination with vitrectomy.
  • patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.

Exclusion criteria

  • Patients with a LARA IOL implanted without concomitant or earlier vitrectomy

Treatment and study plan

Intraocular lens implantation

Procedure

Lens surgery during or before vitrectomy surgery.

Primary outcomes

  1. visual quality

    Time frame: 2 weeks

    Catquest questionnaire measuring activity limitations in daily life due to poor vision

  2. near vision

    Time frame: 2 weeks

    Near Activity Visual Questionnaire (NAVQ) evaluating the near vision

  3. glare

    Time frame: 2 weeks

    The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare

Secondary outcomes

  1. Binocular performance

    Time frame: 2 weeks

    visual acuity

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: LARA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Aug 26, 2022

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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