CataractELVIRA4NCT05376917
Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations
A study testing Zeiss CT Asphina / Zeiss CT Asphina, Zeiss AT Lara/ Zeiss AT Lisa Tri and Zeiss CT Asphina/ Zeiss AT Lara in people with Cataract and Intraocular Lens Implant, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Intraocular Lens Implant
- What is being tested?
- Zeiss CT Asphina / Zeiss CT Asphina, Zeiss AT Lara/ Zeiss AT Lisa Tri and Zeiss CT Asphina/ Zeiss AT Lara
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jan 2023to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHR Metz-Thionville/Hopital de Mercy
Metz, 57085
CHR Metz-Thionville_Hopital Bel Air
Metz, 57085
About this study
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
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.
Read the 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.
- Conditions
- Cataract, Intraocular Lens Implant
- Being tested
- Zeiss CT Asphina / Zeiss CT Asphina, Zeiss AT Lara/ Zeiss AT Lisa Tri, Zeiss CT Asphina/ Zeiss AT Lara, Zeiss AT Lara / Zeiss AT Lara
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeiss CT Asphina / Zeiss CT AsphinaDevice
Monovision with refractive target of -1.50D on the dominated eye
Zeiss AT Lara/ Zeiss AT Lisa TriDevice
Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)
Zeiss CT Asphina/ Zeiss AT LaraDevice
Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)
Zeiss AT Lara / Zeiss AT LaraDevice
Micromonovision with refractive target of -0.75D on the non-dominant eye
| Study group | Role | What they receive |
|---|---|---|
| Zeiss CT Asphina / Zeiss CT Asphina | Experimental | Monovision with refractive target of -1.50 Diopters (D) on the dominated eye Receives: 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) Receives: Device: Zeiss AT Lara/ Zeiss AT Lisa Tri |
| Zeiss CT Asphina/ Zeiss AT Lara | Experimental | Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye) Receives: 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 Receives: Device: Zeiss AT Lara / Zeiss AT Lara |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months after surgery
Secondary outcomes (20)
Uncorrected binocular visual acuity for far vision measured before intervention
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.
Measured: Few days before surgery
Uncorrected binocular visual acuity for intermediate vision measured before intervention
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).
Measured: Few days before surgery
Uncorrected binocular visual acuity for near vision measured before intervention
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).
Measured: Few days before surgery
Uncorrected binocular visual acuity for far vision measured 4 days postoperatively
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.
Measured: 4 days after surgery
Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively
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).
Measured: 4 days after surgery
Uncorrected binocular visual acuity for far vision measured 1 month postoperatively
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.
Measured: 1 month after surgery
Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively
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).
Measured: 1 month after surgery
Uncorrected binocular visual acuity for near vision measured 1 month postoperatively
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).
Measured: 1 month after surgery
Uncorrected binocular visual acuity for far vision measured 3 months postoperatively
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.
Measured: 3 months after surgery
Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively
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).
Measured: 3 months after surgery
Uncorrected binocular visual acuity for near vision measured 3 months postoperatively
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).
Measured: 3 months after surgery
Sunglasses wear frequency 3 months after surgery for far and near visions
Frequency of wearing sunglasses in patients undergoing IOL implant surgery : permanently (yes/no) or occasionally (yes/no) for far and near visions
Measured: 3 months after surgery
Eye tonicity before surgery
Eye pressure measurement millimeters of mercury (mmHg) before intervention
Measured: Few days before surgery
Eye tonicity 4 days postoperatively
Eye pressure measurement millimeters of mercury (mmHg) 4 days postoperatively
Measured: 4 days after surgery
Eye tonicity 1 month postoperatively
Eye pressure measurement millimeters of mercury (mmHg) 1 month postoperatively
Measured: 1 month after surgery
Eye tonicity 3 months postoperatively
Eye pressure measurement millimeters of mercury (mmHg) 3 months postoperatively
Measured: 3 months after surgery
Slit lamp and Macular Optical coherence tomography (OCT) examination 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)
Measured: Few days before surgery
Slit lamp and Macular OCT examination 4 days postoperatively
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)
Measured: 4 days after surgery
Slit lamp and Macular OCT examination 1 month postoperatively
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)
Measured: 1 month after surgery
Slit lamp and Macular OCT examination 3 months postoperatively
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)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start30 Jan 2023
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc PERONE, MD, Principal investigator, Mercy Hospital CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376917
- Sponsor's protocol ID
- 2020-03-CHRMT
- Acronym
- ELVIRA4
- Status last verified
- May 2025
- First submitted
- 28 Mar 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05376917
- Acronym / sponsor ID
- ELVIRA4 / 2020-03-CHRMT
- Conditions
- Cataract, Intraocular Lens Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zeiss CT Asphina / Zeiss CT Asphina | Experimental | Device: Zeiss CT Asphina / Zeiss CT AsphinaMonovision with refractive target of -1.50 Diopters (D) on the dominated eye |
| Zeiss AT Lara/ Zeiss AT Lisa Tri | Experimental | Device: Zeiss AT Lara/ Zeiss AT Lisa TriZeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye) |
| Zeiss CT Asphina/ Zeiss AT Lara | Experimental | Device: Zeiss CT Asphina/ Zeiss AT LaraZeiss CT Asphina/ Zeiss AT Lara (non-dominant eye) |
| Zeiss AT Lara / Zeiss AT Lara | Experimental | Device: Zeiss AT Lara / Zeiss AT LaraMicro-monovision with refractive target of -0.75 Diopters (D) on the non-dominant eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zeiss CT Asphina / Zeiss CT AsphinaMonovision with refractive target of -1.50D on the dominated eye | Device | Zeiss CT Asphina / Zeiss CT Asphina |
| Zeiss AT Lara/ Zeiss AT Lisa TriZeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye) | Device | Zeiss AT Lara/ Zeiss AT Lisa Tri |
| Zeiss CT Asphina/ Zeiss AT LaraZeiss CT Asphina/ Zeiss AT Lara (non-dominant eye) | Device | Zeiss CT Asphina/ Zeiss AT Lara |
| Zeiss AT Lara / Zeiss AT LaraMicromonovision with refractive target of -0.75D on the non-dominant eye | Device | Zeiss AT Lara / Zeiss AT Lara |
Primary outcome
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.
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.
20 secondary outcomes
Uncorrected binocular visual acuity for far vision measured before intervention
Time frame: Few days before surgery
Uncorrected binocular visual acuity for intermediate vision measured before intervention
Time frame: Few days before surgery
Uncorrected binocular visual acuity for near vision measured before intervention
Time frame: Few days before surgery
Uncorrected binocular visual acuity for far vision measured 4 days postoperatively
Time frame: 4 days after surgery
Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively
Time frame: 4 days after surgery
Uncorrected binocular visual acuity for far vision measured 1 month postoperatively
Time frame: 1 month after surgery
Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively
Time frame: 1 month after surgery
Uncorrected binocular visual acuity for near vision measured 1 month postoperatively
Time frame: 1 month after surgery
Uncorrected binocular visual acuity for far vision measured 3 months postoperatively
Time frame: 3 months after surgery
Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively
Time frame: 3 months after surgery
Uncorrected binocular visual acuity for near vision measured 3 months postoperatively
Time frame: 3 months after surgery
Sunglasses wear frequency 3 months after surgery for far and near visions
Time frame: 3 months after surgery
Eye tonicity before surgery
Time frame: Few days before surgery
Eye tonicity 4 days postoperatively
Time frame: 4 days after surgery
Eye tonicity 1 month postoperatively
Time frame: 1 month after surgery
Eye tonicity 3 months postoperatively
Time frame: 3 months after surgery
Slit lamp and Macular Optical coherence tomography (OCT) examination before surgery
Time frame: Few days before surgery
Slit lamp and Macular OCT examination 4 days postoperatively
Time frame: 4 days after surgery
Slit lamp and Macular OCT examination 1 month postoperatively
Time frame: 1 month after surgery
Slit lamp and Macular OCT examination 3 months postoperatively
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Related trials for Cataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
RecruitingObservational study
Capella Scientia Development Study
Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc PERONE, MD principal investigator
Mercy Hospital CHR Metz Thionville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zeiss CT Asphina / Zeiss CT Asphina, Zeiss AT Lara/ Zeiss AT Lisa Tri and Zeiss CT Asphina/ Zeiss AT Lara in people with Cataract and Intraocular Lens Implant, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery (time frame: Few days before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.