NCT05376917

Brief Summary

This is multicenter, prospective, comparative and randomized study focusing on the evolution of the quality of Life and Uncorrected Binocular Visual Acuity (UBVA) evaluation at 3 months after cataract surgery in patients who underwent 4 different types of intraocular lens Implant (IOL) combinations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

March 28, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

2.3 years

First QC Date

March 28, 2022

Last Update Submit

May 27, 2025

Conditions

CataractIntraocular Lens Implant

Outcome Measures

Primary Outcomes (2)

  • National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery

    Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured before intervention. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.

    Few days before surgery

  • National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery

    Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured 3 months after intervention. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire-25 (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.

    3 months after surgery

Secondary Outcomes (20)

  • Uncorrected binocular visual acuity for far vision measured before intervention

    Few days before surgery

  • Uncorrected binocular visual acuity for intermediate vision measured before intervention

    Few days before surgery

  • Uncorrected binocular visual acuity for near vision measured before intervention

    Few days before surgery

  • Uncorrected binocular visual acuity for far vision measured 4 days postoperatively

    4 days after surgery

  • Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively

    4 days after surgery

  • +15 more secondary outcomes

Study Arms (4)

Zeiss CT Asphina / Zeiss CT Asphina

EXPERIMENTAL

Monovision with refractive target of -1.50 Diopters (D) on the dominated eye

Device: Zeiss CT Asphina / Zeiss CT Asphina

Zeiss AT Lara/ Zeiss AT Lisa Tri

EXPERIMENTAL

Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)

Device: Zeiss AT Lara/ Zeiss AT Lisa Tri

Zeiss CT Asphina/ Zeiss AT Lara

EXPERIMENTAL

Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)

Device: Zeiss CT Asphina/ Zeiss AT Lara

Zeiss AT Lara / Zeiss AT Lara

EXPERIMENTAL

Micro-monovision with refractive target of -0.75 Diopters (D) on the non-dominant eye

Device: Zeiss AT Lara / Zeiss AT Lara

Interventions

Zeiss CT Asphina / Zeiss CT AsphinaDEVICE

Monovision with refractive target of -1.50D on the dominated eye

Zeiss CT Asphina / Zeiss CT Asphina
Zeiss AT Lara/ Zeiss AT Lisa TriDEVICE

Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)

Zeiss AT Lara/ Zeiss AT Lisa Tri
Zeiss CT Asphina/ Zeiss AT LaraDEVICE

Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)

Zeiss CT Asphina/ Zeiss AT Lara
Zeiss AT Lara / Zeiss AT LaraDEVICE

Micromonovision with refractive target of -0.75D on the non-dominant eye

Zeiss AT Lara / Zeiss AT Lara

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient suffering from bilateral cataract and undergoing cataract surgery
  • Patient with preoperative visual acuity ≤ 8/10th Monoyer (≥+ 0.1 logMar) in each eye
  • Patient with nuclear color (NC), cortical (C) or posterior capsule opacity (P) cataract of normal to severe density in the Lens Opacities Classification System III (LOCSIII)
  • Patient with cortical cataracts classified C1 to C5
  • Patient with cataracts classified as nuclear opalescence (NO)1 to NO4 and nuclear color (NC)1 to NC4
  • Patient with posterior capsule opacity cataracts classified as grade 5 (P1-P5)
  • Patient affiliated to a social security scheme
  • Patient having given written consent

You may not qualify if:

  • Patient with biometrics ≤ 17 Diopters (D) and ≥ 28D
  • Patient with a history (ATCD) of refractive surgery
  • Patient with ATCD intraocular surgery
  • Patient with ATCD strabismus
  • Patient with amblyopia
  • Patient with monophthalmos
  • Patient with age-related macular degeneration (AMD)
  • Patient with glaucoma
  • Patient with diabetic retinopathy or maculopathy
  • Patient with progressive or old ocular inflammatory disease
  • Patient presenting with a very dense nuclear cataract (Stage NO5-6, NC5-6 on the LOCSIII classification), sources of preoperative complication
  • Patient with keratoconus
  • Patient with pseudoexfoliative syndrome
  • Patient with pigment dispersion
  • Patient with traumatic cataract
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

CHR Metz-Thionville_Hopital Bel Air

Metz, 57085, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jean-Marc PERONE, MD

    Mercy Hospital CHR Metz Thionville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 17, 2022

Study Start

January 30, 2023

Primary Completion

May 21, 2025

Study Completion

May 21, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations

FR(2)