Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05427526
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitreous Disorder; Cataract	Procedure: intraocular lens implantation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 vitrectomygroup 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: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes
• Actual Study Start Date: Feb 14, 2022
• Anticipated Primary Completion Date: Feb 14, 2023
• Anticipated Study Completion Date: Feb 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group 1: LARA IOL implanted in combination with vitrectomy. intraocular lens implantation in combination with vitrectomy	Procedure: intraocular lens implantation; Lens surgery during or before vitrectomy surgery.
Active Comparator: group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy intraocular lens implantation during surgery for cataract secondary to vitrectomy	Procedure: intraocular lens implantation; Lens surgery during or before vitrectomy surgery.

Outcome Measures

Primary Outcome Measures

1. visual quality [2 weeks]

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

2. near vision [2 weeks]

   Near Activity Visual Questionnaire (NAVQ) evaluating the near vision

3. glare [2 weeks]

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

Secondary Outcome Measures

1. Binocular performance [2 weeks]

   visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven

Investigators

• Principal Investigator: Peter Stalmans, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT05427526
• Other Study ID Numbers: S65356
• First Posted: Jun 22, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universitaire Ziekenhuizen Leuven: LARA EDOF lens; Intra ocular lensimplantation; cataract; vitrectomy
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jul 5, 2022