search
Back to results

Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes (LARA)

Primary Purpose

Vitreous Disorder, Cataract

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
intraocular lens implantation
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vitreous Disorder focused on measuring LARA EDOF lens, Intra ocular lensimplantation, cataract, vitrectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1: LARA IOL implanted in combination with vitrectomy.

group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy

Arm Description

intraocular lens implantation in combination with vitrectomy

intraocular lens implantation during surgery for cataract secondary to vitrectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Binocular performance
visual acuity

Full Information

First Posted
January 26, 2022
Last Updated
August 25, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
search

1. Study Identification

Unique Protocol Identification Number
NCT05427526
Brief Title
Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
Acronym
LARA
Official Title
Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Disorder, Cataract
Keywords
LARA EDOF lens, Intra ocular lensimplantation, cataract, vitrectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group 1: patients that had a LARA IOL implanted in combination with vitrectomy group 2: patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1: LARA IOL implanted in combination with vitrectomy.
Arm Type
Active Comparator
Arm Description
intraocular lens implantation in combination with vitrectomy
Arm Title
group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy
Arm Type
Active Comparator
Arm Description
intraocular lens implantation during surgery for cataract secondary to vitrectomy
Intervention Type
Procedure
Intervention Name(s)
intraocular lens implantation
Intervention Description
Lens surgery during or before vitrectomy surgery.
Primary Outcome Measure Information:
Title
visual quality
Description
Catquest questionnaire measuring activity limitations in daily life due to poor vision
Time Frame
2 weeks
Title
near vision
Description
Near Activity Visual Questionnaire (NAVQ) evaluating the near vision
Time Frame
2 weeks
Title
glare
Description
The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Binocular performance
Description
visual acuity
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Stalmans, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

We'll reach out to this number within 24 hrs