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Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations (ELVIRA4)

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ClinicalTrials.gov Identifier: NCT05376917
Recruitment Status : Not yet recruiting
First Posted : May 17, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

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.

Condition or disease Intervention/treatment Phase
Cataract Intraocular Lens Implant Device: Zeiss CT Asphina / Zeiss CT Asphina Device: Zeiss AT Lara/ Zeiss AT Lisa Tri Device: Zeiss CT Asphina/ Zeiss AT Lara Device: Zeiss AT Lara / Zeiss AT Lara Not Applicable

Detailed Description:

Cataract, linked to the loss of transparency of the lens, is the leading cause of blindness in the world. It requires exclusively surgical treatment. Cataract surgery by ultrasonic phacoemulsification is the most common surgical procedure in France (800,000/year). The lens is removed and replaced with an artificial intraocular lens.

There are different types of implants that can be used. The simplest is the monofocal implant which is implanted in such a way as to correct "only far or near vision". For near vision or vice versa, it is therefore necessary to wear corrective lenses after the operation. A technique that eliminates the need for distance and near correction is based on monovision. This is a presbyopia compensation technique that aims to induce a slight myopization of one eye for near vision (usually the dominated eye) the other eye being intended for distance vision (dominant eye). There is therefore a difference in correction and perception of the images. Depending on the fixed distance, one eye will see sharp, the other less clear, even blurry. This difference can lead to a reduction in the perception of relief.

Other methods of compensating for presbyopia include the use of so-called multifocal or extended depth of field implants; they are also not devoid of sometimes annoying side effects (in particular possible halos around light sources at night) which can lead in rare cases to the removal of the intraocular lens.

However, patient requirements in terms of comfort of vision and independence from glasses are increasingly high and patients themselves are increasingly informed of the existence of multifocal implants. The choice of the intraocular implant to use is therefore a real challenge, especially since patients are often still active on a professional level.

Moreover, there is a lack of scientific consensus related to the choice of implants, during a surgical treatment of cataract lenses by phakoexeresis, for otherwise healthy eyes and in a subject wishing to no longer wear glasses postoperatively. . Different studies have emerged comparing the bilateral implantation of different types of multifocal implants with each other, but there is little work concerning mixed batches of "mix - match" implants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Quality of Life and Uncorrected Binocular Visual Acuity (UBVA) Evaluation in Patients Undergoing Cataract Surgery Using 4 Different Types of Lens Implant Combinations: a Multicenter, Prospective, Comparative and Randomized Study
Estimated Study Start Date : December 25, 2022
Estimated Primary Completion Date : March 25, 2023
Estimated Study Completion Date : March 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Zeiss CT Asphina / Zeiss CT Asphina
Monovision with refractive target of -1.50 Diopters (D) on the dominated eye
Device: Zeiss CT Asphina / Zeiss CT Asphina
Monovision with refractive target of -1.50D on the dominated eye

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

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

Experimental: Zeiss AT Lara / Zeiss AT Lara
Micro-monovision with refractive target of -0.75 Diopters (D) on the non-dominant eye
Device: Zeiss AT Lara / Zeiss AT Lara
Micromonovision with refractive target of -0.75D on the non-dominant eye




Primary Outcome Measures :
  1. National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery [ Time Frame: Few days before 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.


  2. National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery [ Time Frame: 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.



Secondary Outcome Measures :
  1. Uncorrected binocular visual acuity for far vision measured before intervention [ Time Frame: Few days before surgery ]
    Uncorrected binocular visual acuity for distance vision is measured before intervention using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.

  2. Uncorrected binocular visual acuity for intermediate vision measured before intervention [ Time Frame: Few days before surgery ]

    Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for intermediate vision.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  3. Uncorrected binocular visual acuity for near vision measured before intervention [ Time Frame: Few days before surgery ]

    Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for near vision.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  4. Uncorrected binocular visual acuity for far vision measured 4 days postoperatively [ Time Frame: 4 days after surgery ]
    Uncorrected binocular visual acuity for far vision is measured 4 days postoperatively using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.

  5. Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively [ Time Frame: 4 days after surgery ]

    Uncorrected binocular visual acuity for intermediate vision is measured 4 days postoperatively using Parinaud scale.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  6. Uncorrected binocular visual acuity for far vision measured 1 month postoperatively [ Time Frame: 1 month after surgery ]
    Uncorrected binocular visual acuity is measured 1 month after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.

  7. Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively [ Time Frame: 1 month after surgery ]

    Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  8. Uncorrected binocular visual acuity for near vision measured 1 month postoperatively [ Time Frame: 1 month after surgery ]

    Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  9. Uncorrected binocular visual acuity for far vision measured 3 months postoperatively [ Time Frame: 3 months after surgery ]
    Uncorrected binocular visual acuity is measured 3 months after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.

  10. Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively [ Time Frame: 3 months after surgery ]

    Uncorrected binocular visual acuity for intermediate vision is measured 3 months after surgery using Parinaud scale.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  11. Uncorrected binocular visual acuity for near vision measured 3 months postoperatively [ Time Frame: 3 months after surgery ]

    Uncorrected binocular visual acuity for near vision is measured 3 months after surgery using Parinaud scale.

    The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).


  12. Sunglasses wear frequency 3 months after surgery for far and near visions [ Time Frame: 3 months after surgery ]
    Frequency of wearing sunglasses in patients undergoing IOL implant surgery : permanently (yes/no) or occasionally (yes/no) for far and near visions

  13. Eye tonicity before surgery [ Time Frame: Few days before surgery ]
    Eye pressure measurement millimeters of mercury (mmHg) before intervention

  14. Eye tonicity 4 days postoperatively [ Time Frame: 4 days after surgery ]
    Eye pressure measurement millimeters of mercury (mmHg) 4 days postoperatively

  15. Eye tonicity 1 month postoperatively [ Time Frame: 1 month after surgery ]
    Eye pressure measurement millimeters of mercury (mmHg) 1 month postoperatively

  16. Eye tonicity 3 months postoperatively [ Time Frame: 3 months after surgery ]
    Eye pressure measurement millimeters of mercury (mmHg) 3 months postoperatively

  17. Slit lamp and Macular Optical coherence tomography (OCT) examination before surgery [ Time Frame: Few days before surgery ]
    Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)

  18. Slit lamp and Macular OCT examination 4 days postoperatively [ Time Frame: 4 days after surgery ]
    Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)

  19. Slit lamp and Macular OCT examination 1 month postoperatively [ Time Frame: 1 month after surgery ]
    Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)

  20. Slit lamp and Macular OCT examination 3 months postoperatively [ Time Frame: 3 months after surgery ]
    Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient suffering from bilateral cataract and undergoing cataract surgery
  • Patient with preoperative visual acuity ≤6/10th Monoyer (≥+ 0.2 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

Exclusion Criteria:

  • Patient with biometrics < 16 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
  • Patient with astigmatism conforming to the rule > 1.5 Diopters (D) or inverse to the rule > 1 Diopter (D)
  • Patient with abnormal ocular morphology
  • Patient with abnormal keratometry
  • Insulin-dependent diabetics and/or diabetics with retinal complications
  • Pregnant or breastfeeding women
  • Patient under legal protection (guardianship, curators, safeguard of justice)
  • Person deprived of liberty
  • Patient wishing to see near or far exclusively

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05376917


Contacts
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Contact: Jean-Marc PERONE, MD 387557777 ext 0033 jm.perone@chr-metz-thionville.fr
Contact: Arpiné EL NAR, PhD 387557766 ext 0033 a.elnar@chr-metz-thionville.fr

Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
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Principal Investigator: Jean-Marc PERONE, MD Mercy Hospital CHR Metz Thionville
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT05376917    
Other Study ID Numbers: 2020-03-CHRMT
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases