Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

Not Applicable

Completed

• Conditions: Vitreous Disorder; Cataract
• Interventions: Procedure: intraocular lens implantation

• Registration Number: NCT05427526
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study Start: 2022-02-14
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-22
• Status Verified: 2022-08
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-17
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1: LARA IOL implanted in combination with vitrectomy.	intraocular lens implantation	intraocular lens implantation in combination with vitrectomy
group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy	intraocular lens implantation	intraocular lens implantation during surgery for cataract secondary to vitrectomy

Primary Outcome Measures

Name	Time	Method
visual quality	2 weeks	Catquest questionnaire measuring activity limitations in daily life due to poor vision
near vision	2 weeks	Near Activity Visual Questionnaire (NAVQ) evaluating the near vision
glare	2 weeks	The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare

Secondary Outcome Measures

Name	Time	Method
Binocular performance	2 weeks	visual acuity

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium