Cataract AfterNCT04387721
Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation
An observational study of Cataract After and Astigmatism, run by Enrique Ordiñaga-Monreal, OD, MSc at 1 site in Spain.
Trial summary
MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract After, Astigmatism, IOL
- What is being tested?
- Kind of trifocal IOL
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jul 2019to Jul 2021
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The field in which it will carry out the study is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.
Who may be able to join
- Bilateral surgery performed by the same surgeon
- IOLs implanted IOLs FineVision (MicroF) and FineVision Toric (PodFT)
- Patients with pre-surgery corneal astigmatism less than 2.5 D
- Patients whose pupillary diameter in physiological position (conditions of lower photopic pupil) not over 4 mm.
Who cannot join
- Post-surgical refractive residual astigmatisms ≧ 1.55D
- Previous corneal or intraocular surgeries
- Active diseases
- Eye complications during the 3-month follow-up
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Oftalmológica TACIR
Barcelona, 08022
Ordiñaga-Monreal Enrique, OD, 934179803, e.ordinaga@clinicatacir.com
About this study
MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.
SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.
Read the detailed description
It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.
- Conditions
- Cataract After, Astigmatism, IOL, Visual Acuity
- Being tested
- Kind of trifocal IOL
- Keywords
- CSF, Contrast Sensitivity, Trifocal IOL
- Medical subject headings
- Capsule Opacification, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kind of trifocal IOLOther
Also called FineVision IOL, FineVision Toric IOL
Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D
| Study group | Role | What they receive |
|---|---|---|
| Trifocal IOL(Finevision IOL, PhysIOL) | We will divide the sample into two groups of patients depending on the IOL implanted First group: FineVision Receives: Other: Kind of trifocal IOL | |
| Trifocal toric IOL (Finevision Toric IOL, PhysIOL) | We will divide the sample into two groups of patients depending on the IOL implanted: Second group: FineVisionToric Receives: Other: Kind of trifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity will be measured at distance, intermediate distance (67 cm) and near (40 cm). Visual acuities will be obtained with logarithmic notation
Measured: 3 months following cataract surgery
Contrast Sensitivity Function (CSF)
Contrast sensitivity will be measured at far, intermediate distance (67 cm) and near (40 cm).
Measured: 3 months following cataract surgery
Secondary outcomes (1)
Differences between groups
Results will be compared between groups.
Measured: 3 months following cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start29 Jul 2019
- Primary completion1 Mar 2020
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract AfterStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enrique Ordiñaga-Monreal, OD, MSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enrique Ordiñaga-Monreal, OD, MSc, Clinica Oftalmologica TACIR
- Investigators
- Enrique Ordiñaga-Monreal, OD, Principal investigator, Clinica Oftalmologica TACIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387721
- Sponsor's protocol ID
- EC042019
- Other IDs
- 2019/65-OFT-CMT
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT04387721
- Acronym / sponsor ID
- EC042019
- Conditions
- Cataract After, Astigmatism, IOL, Visual Acuity
- Keywords
- CSF, Contrast Sensitivity, Trifocal IOL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Enrique Ordiñaga-Monreal, OD, MScUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 14 May 2020 (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.
MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.
SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.
Detailed description
It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifocal IOL(Finevision IOL, PhysIOL) | – | Other: Kind of trifocal IOLWe will divide the sample into two groups of patients depending on the IOL implanted First group: FineVision |
| Trifocal toric IOL (Finevision Toric IOL, PhysIOL) | – | Other: Kind of trifocal IOLWe will divide the sample into two groups of patients depending on the IOL implanted: Second group: FineVisionToric |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The field in which it will carry out the study is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.
Key inclusion criteria (4 listed)
- Bilateral surgery performed by the same surgeon
- IOLs implanted IOLs FineVision (MicroF) and FineVision Toric (PodFT)
- Patients with pre-surgery corneal astigmatism less than 2.5 D
- Patients whose pupillary diameter in physiological position (conditions of lower photopic pupil) not over 4 mm.
Key exclusion criteria (4 listed)
- Post-surgical refractive residual astigmatisms ≧ 1.55D
- Previous corneal or intraocular surgeries
- Active diseases
- Eye complications during the 3-month follow-up
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 |
|---|---|---|
| Kind of trifocal IOLAlso: FineVision IOL, FineVision Toric IOLPatients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D | Other | Trifocal IOL(Finevision IOL, PhysIOL), Trifocal toric IOL (Finevision Toric IOL, PhysIOL) |
Primary outcome
Visual Acuity
Time frame: 3 months following cataract surgery
Visual acuity will be measured at distance, intermediate distance (67 cm) and near (40 cm). Visual acuities will be obtained with logarithmic notation
Contrast Sensitivity Function (CSF)
Time frame: 3 months following cataract surgery
Contrast sensitivity will be measured at far, intermediate distance (67 cm) and near (40 cm).
1 secondary outcome
Differences between groups
Time frame: 3 months following cataract surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: No
Related trials for Cataract After
Not yet recruitingPhase 4
Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery
Dry Eye, Dry Eye Disease (DED)
Active, not recruiting
Evaluation of the Effects of Education and Counseling Provided to Patients Via Distance Nursing After Cataract Surgery on Regular Use of Medications and Patient Satisfaction. CAT-TELEMED (Cataract - Telemedicine) TNCat-25 (Tele-Nursing Cataract - 2025)
Cataract Patients, Cataract After Surgery
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.
Enrique Ordiñaga-Monreal, OD principal investigator
Clinica Oftalmologica TACIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract After and Astigmatism, run by Enrique Ordiñaga-Monreal, OD, MSc at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Ordiñaga-Monreal, OD (934179803, e.ordinaga@clinicatacir.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 3 months following cataract 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 14 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.