Intraocular Lens ImplantationORAVSCTRLNCT06219252
Intraoperative Aberrometry vs Conventional Intraocular Lens Calculation, a Prospective Study.
A study testing Intraoperative aberrometer and Preoperative intraocular lens calculation in people with Intraocular Lens Implantation and Cataract, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
Trial summary
the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) . Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Lens Implantation, Cataract, Humans
- What is being tested?
- Intraoperative aberrometer and Preoperative intraocular lens calculation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteMexico
- Study dates
- 3 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer.
Who cannot join
- glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de oftalmología Fundación Conde de Valenciana
Mexico City, Cuauhtemoc, 06800
Diego Zamora- de la Cruz, MD, 5554421700 ext. 3714, diego.zamora@institutodeoftalmologia.org
About this study
Official title: Intraoperative Aberrometry vs Conventional Introcular Lens Calculation ( Barrett Universal II / Barrett True K ), Refractive and Visual Outcomes, a Prospective Study.
the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) .
Researchers will compare ORA group vs control to see changes in spherical equivalent and uncorrected distance visual acuity
Read the detailed description
Studies have described a small difference between ORA (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( Barrett Universal II ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made.
The investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.
- Conditions
- Intraocular Lens Implantation, Cataract, Humans, Ocular, Refraction
- Being tested
- Intraoperative aberrometer, Preoperative intraocular lens calculation
- Keywords
- biometry, aberrometry, prospective study
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative aberrometerDevice
Also called ORA
the patient intraocular lens will be optimized during the aphakic period after cataract extraction and before intraocular lens implantation, this will produce a possible change in the dioptric power of the intraocular lens
Preoperative intraocular lens calculationOther
Also called Barrett Universal II
the intraocular lens in this group will be calculated preoperatively with Barrett Universal II formula
| Study group | Role | What they receive |
|---|---|---|
| ORA group | Experimental | the intraocular lens calculation in this group will be optimized by the intraoperative aberrometer (ORA) Receives: Device: Intraoperative aberrometer |
| Control group | Active comparator | Barrett universal II will be used in the control group. Receives: Other: Preoperative intraocular lens calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent
Spherical equivalent values at 90 days of the postoperative period
Measured: 90 days of the postoperative period
Secondary outcomes (1)
uncorrected distance visual acuity
uncorrected distance visual acuity at 90 days of the postoperative period
Measured: 90 days of the postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start3 Nov 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Lens ImplantationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANGEL NAVA - CASTAÑEDA, MD, Principal investigator, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219252
- Sponsor's protocol ID
- CI-005-2023
- Acronym
- ORAVSCTRL
- Status last verified
- May 2025
- First submitted
- 12 Jan 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Aberrometry vs Conventional Introcular Lens Calculation ( Barrett Universal II / Barrett True K ), Refractive and Visual Outcomes, a Prospective Study.
- ClinicalTrials.gov ID
- NCT06219252
- Acronym / sponsor ID
- ORAVSCTRL / CI-005-2023
- Conditions
- Intraocular Lens Implantation, Cataract, Humans, Ocular, Refraction
- Keywords
- biometry, aberrometry, prospective study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Oftalmología Fundación Conde de ValencianaUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2024 (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 goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) .
Researchers will compare ORA group vs control to see changes in spherical equivalent and uncorrected distance visual acuity
Detailed description
Studies have described a small difference between ORA (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( Barrett Universal II ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made.
The investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORA group | Experimental | Device: Intraoperative aberrometerthe intraocular lens calculation in this group will be optimized by the intraoperative aberrometer (ORA) |
| Control group | Active comparator | Other: Preoperative intraocular lens calculationBarrett universal II will be used in the control group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer.
Key exclusion criteria (1 listed)
- glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.
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 |
|---|---|---|
| Intraoperative aberrometerAlso: ORAthe patient intraocular lens will be optimized during the aphakic period after cataract extraction and before intraocular lens implantation, this will produce a possible change in the dioptric power of the intraocular lens | Device | ORA group |
| Preoperative intraocular lens calculationAlso: Barrett Universal IIthe intraocular lens in this group will be calculated preoperatively with Barrett Universal II formula | Other | Control group |
Primary outcome
spherical equivalent
Time frame: 90 days of the postoperative period
Spherical equivalent values at 90 days of the postoperative period
1 secondary outcome
uncorrected distance visual acuity
Time frame: 90 days of the postoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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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.
ANGEL NAVA - CASTAÑEDA, MD principal investigator
INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative aberrometer and Preoperative intraocular lens calculation in people with Intraocular Lens Implantation and Cataract, run by Instituto de Oftalmología Fundación Conde de Valenciana at 1 site in Mexico.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 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 1 site in Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DIEGO ZAMORA - DE LA CRUZ, MD (5554421700 ext. 3141, DIEGO.ZAMORA@INSTITUTODEOFTALMOLOGIA.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spherical equivalent (time frame: 90 days of the postoperative period). 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 2025.