NCT05427526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

January 26, 2022

Last Update Submit

August 25, 2022

Conditions

Vitreous DisorderCataract

Keywords

LARA EDOF lensIntra ocular lensimplantationcataractvitrectomy

Outcome Measures

Primary Outcomes (3)

  • visual quality

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

    2 weeks

  • near vision

    Near Activity Visual Questionnaire (NAVQ) evaluating the near vision

    2 weeks

  • glare

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

    2 weeks

Secondary Outcomes (1)

  • Binocular performance

    2 weeks

Study Arms (2)

group 1: LARA IOL implanted in combination with vitrectomy.

ACTIVE COMPARATOR

intraocular lens implantation in combination with vitrectomy

Procedure: intraocular lens implantation

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

ACTIVE COMPARATOR

intraocular lens implantation during surgery for cataract secondary to vitrectomy

Procedure: intraocular lens implantation

Interventions

intraocular lens implantationPROCEDURE

Lens surgery during or before vitrectomy surgery.

group 1: LARA IOL implanted in combination with vitrectomy.group 2: LARA IOL implanted in during surgery for cataract secondary to vitrectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Cataract

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Peter Stalmans, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

June 22, 2022

Study Start

February 14, 2022

Primary Completion

August 17, 2022

Study Completion

August 17, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)