Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

Cataract Clinical Trial

— LARA  

Official title:

Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427526
• Other study ID #: S65356
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: August 17, 2022

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 17, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Vitreous Disorder

Intervention

Procedure:
• intraocular lens implantation
Lens surgery during or before vitrectomy surgery.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual quality	Catquest questionnaire measuring activity limitations in daily life due to poor vision	2 weeks
Primary	near vision	Near Activity Visual Questionnaire (NAVQ) evaluating the near vision	2 weeks
Primary	glare	The Assessment of Photic Phenomena and Lens Effects (APPLES) questionnaire assessing the glare	2 weeks
Secondary	Binocular performance	visual acuity	2 weeks