Cataract CongenitalNCT04872829
Multifocal vs Monofocal IOL in Congenital Cataract Surgery
An observational study of Cataract Congenital, run by Bambino Gesù Hospital and Research Institute.
Trial summary
The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs. Read more about this study
- Who is it for?
- Ages 6 to 12 months
- Conditions the study is for
- Cataract Congenital
- What is being tested?
- cataract surgery
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2008to 30 Jun 2015
- 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 6 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. All patients were directed to our hospital from primary care ophthalmologists or pediatricians
Who may be able to join
- unilateral congenital cataract
- bilateral congenital cataract
Who cannot join
- other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts)
- systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)
About this study
Official title: Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery
The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.
Read the detailed description
PURPOSE: To assess the impact on visual development of multifocal versus monofocal intraocular lenses (IOLs) implantation in children following congenital cataract surgery.
DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.
- Conditions
- Cataract Congenital
- Being tested
- cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryDevice
All patients underwent cataract surgery under 1 year of age (mean age 8 months, range 6-12) performed with the same surgical technique: two 1.2 mm clear corneal incision, continuous curvilinear capsulorhexis with a diameter of approximately 6.0 mm and intraocular lens implantation, posterior capsulotomy and anterior vitrectomy.
IOL power was calculated using Sanders-Retzlaff-Kraff (SRK)/II formula. Multifocal IOL implantated was Alcon AcrySof ReSTOR SN60D3, while the monofocal one was Alcon AcrySof SN60AT.
According to the Infant Aphakia treatment Study, the IOL power was calculated as a function of the child age17, with an undercorrection ranging from 4 to 6 D.
| Study group | Role | What they receive |
|---|---|---|
| multifocal IOL group | patients with unilateral and bilateral multifocal IOL Receives: Device: cataract surgery | |
| monofocal IOL group | patients with unilateral and bilateral monofocal IOL Receives: Device: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean CDVA
Corrected distance visual acuity (CDVA), calculated in logarithm of the minimum angle of resolution (logMAR), using standard Snellen charts
Measured: CDVA was evaluated after 4 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Jun 2008
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cataract CongenitalStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
- Investigators
- Luca Buzzonetti, MD, Principal investigator, Bambino Gesù Children's Hospital, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872829
- Sponsor's protocol ID
- L121
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data are stored in the Bambino Gesù Children's Hospital data base
Publications
Buzzonetti L, Petroni S, De Sanctis CM, Valente P, Federici M, Benassi C, Iarossi G. Comparative analysis of visual outcomes of multifocal and monofocal intraocular lenses in congenital cataract surgery. J Cataract Refract Surg. 2022 Jan 1;48(1):56-60. doi: 10.1097/j.jcrs.0000000000000705.
PubMed 34054076
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT04872829
- Acronym / sponsor ID
- L121
- Conditions
- Cataract Congenital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 5 May 2021 (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.
The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.
Detailed description
PURPOSE: To assess the impact on visual development of multifocal versus monofocal intraocular lenses (IOLs) implantation in children following congenital cataract surgery.
DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multifocal IOL group | – | Device: cataract surgerypatients with unilateral and bilateral multifocal IOL |
| monofocal IOL group | – | Device: cataract surgerypatients with unilateral and bilateral monofocal IOL |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. All patients were directed to our hospital from primary care ophthalmologists or pediatricians
Key inclusion criteria (2 listed)
- unilateral congenital cataract
- bilateral congenital cataract
Key exclusion criteria (2 listed)
- other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts)
- systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)
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 |
|---|---|---|
| cataract surgeryAll patients underwent cataract surgery under 1 year of age (mean age 8 months, range 6-12) performed with the same surgical technique: two 1.2 mm clear corneal incision, continuous curvilinear capsulorhexis with a diameter of approximately 6.0 mm and intraocular lens implantation, posterior capsulotomy and anterior vitrectomy. IOL power was calculated using Sanders-Retzlaff-Kraff (SRK)/II formula. Multifocal IOL implantated was Alcon AcrySof ReSTOR SN60D3, while the monofocal one was Alcon AcrySof SN60AT. According to the Infant Aphakia treatment Study, the IOL power was calculated as a function of the child age17, with an undercorrection ranging from 4 to 6 D. | Device | monofocal IOL group, multifocal IOL group |
Primary outcome
Mean CDVA
Time frame: CDVA was evaluated after 4 years of age.
Corrected distance visual acuity (CDVA), calculated in logarithm of the minimum angle of resolution (logMAR), using standard Snellen charts
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 5 May 2021.
- Derived from this study: PubMed 34054076Buzzonetti L, Petroni S, De Sanctis CM, Valente P, Federici M, Benassi C, Iarossi G. Comparative analysis of visual outcomes of multifocal and monofocal intraocular lenses in congenital cataract surgery. J Cataract Refract Surg. 2022 Jan 1;48(1):56-60. doi: 10.1097/j.jcrs.0000000000000705.
- Individual participant dataSharing planned: No. All the data are stored in the Bambino Gesù Children's Hospital data base
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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.
Luca Buzzonetti, MD principal investigator
Bambino Gesù Children's Hospital, Rome, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Congenital, run by Bambino Gesù Hospital and Research Institute.
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 2 inclusion and 2 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Mean CDVA (time frame: CDVA was evaluated after 4 years of age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872829, which also lists 1 linked publication.
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 5 May 2021.