CataractORIONNCT06377007
Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION)
A study testing IOLMaster 700 (Carl Zeiss Meditec AG) and ARGOS (Movu/Santec; distributed by Alcon) in people with Cataract, run by Walailak University at 1 site in Thailand.
Trial summary
This prospective, single-centre, randomized, parallel-group comparative clinical study evaluated the refractive prediction accuracy of two swept-source optical coherence tomography (SS-OCT) biometers in a Thai cataract surgery cohort. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- IOLMaster 700 (Carl Zeiss Meditec AG) and ARGOS (Movu/Santec; distributed by Alcon)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2024to 31 Jan 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40-90 years presenting with visually significant age-related cataract scheduled for elective phacoemulsification with implantation of a TECNIS Monofocal one-piece IOL (model GCB00V).
Who cannot join
- Corneal astigmatism greater than 1.00 D on either device
- Central corneal thickness outside 490-600 µm
- Severe dry eye precluding reliable keratometry
- Rigid or soft contact lens wear within 2 months prior to evaluation
- Previous corneal refractive surgery or other corneal pathology
- Prior intraocular surgery (other than uneventful cataract surgery in the fellow eye)
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- Clinically significant retinal pathology potentially affecting refractive outcome (e.g., epiretinal membrane, diabetic macular edema, advanced age-related macular degeneration)
- Intraoperative complications including posterior capsule rupture, vitreous loss, or zonular dehiscence
- Dense cataract that does not allow measurements with optical biometry
- Inability to attend follow-up
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Walailak University
Nakhon Si Thammarat, Changwat Nakhon Si Thammarat, 80160
About this study
Official title: Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION): A Non-Inferiority Randomized Clinical Trials
This prospective, single-centre, randomized, parallel-group comparative clinical study evaluated the refractive prediction accuracy of two swept-source optical coherence tomography (SS-OCT) biometers in a Thai cataract surgery cohort. The ARGOS biometer applies segmental refractive indices to individual ocular segments, whereas the IOLMaster 700 applies an equivalent refractive index to the whole eye. Each device is conventionally paired with a different keratometry-formula combination: ARGOS with the standard Barrett Universal II (Barrett UII K), and IOLMaster 700 with the Barrett Universal II using total keratometry (Barrett UII TK). The study compared these two device-formula pairings as they are used in routine clinical practice. Both biometers were performed on every eye on the same day, enabling a within-subject paired comparison of biometric agreement and refractive prediction error at one month after phacoemulsification cataract surgery with implantation of a TECNIS Monofocal one-piece IOL (model GCB00V)
Read the detailed description
One hundred and forty-four eyes of 144 consecutive Thai cataract surgery patients aged 40-90 years presenting with visually significant age-related cataract were enrolled at the Ophthalmology Service, Walailak University Hospital between May 2024 and December 2024. Participants underwent preoperative biometric measurement on the same day with both the ARGOS (software version A2.4; Movu, Inc., a Santec company; distributed by Alcon Laboratories) and the IOLMaster 700 (software version 1.90.10; Carl Zeiss Meditec AG) by a single experienced operator. Participants were randomized 1:1 between two IOL-selection arms using a computer-generated allocation sequence (Research Randomizer, blocks of 12): Group 1 used the IOLMaster 700 with the Barrett Universal II TK formula for IOL power selection, and Group 2 used the ARGOS with the standard Barrett Universal II K formula. Allocation was concealed from the enrolling surgeon until completion of preoperative biometry. Participants were masked to the device-formula arm. All cataract surgeries were performed by four experienced surgeons (in approximately equal numbers) using a standardized phacoemulsification technique with in-the-bag implantation of the TECNIS Monofocal one-piece IOL (model GCB00V; Johnson \& Johnson Vision). The primary outcome was mean absolute prediction error (MAE) at one month postoperatively, assessed by a masked refractionist using subjective manifest refraction. Secondary outcomes were median absolute prediction error and the proportion of eyes within ±0.25 D and ±0.50 D of target refraction. One eye per patient was enrolled. The study was registered prospectively as a non-inferiority trial; the implemented analysis is reported as a within-subject paired comparative analysis with descriptive accuracy thresholds rather than as a formal non-inferiority hypothesis test (CONSORT item 3b). The total enrolled sample was 144 patients; within-subject paired analyses included 138 eyes with complete data for both devices.
- Conditions
- Cataract
- Being tested
- IOLMaster 700 (Carl Zeiss Meditec AG), ARGOS (Movu/Santec; distributed by Alcon)
- Keywords
- Biometry, SS-OCT, IOLMaster700, Argos
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOLMaster 700 (Carl Zeiss Meditec AG)Device
Preoperative biometric measurement using the IOLMaster 700 (software version 1.90.10). IOL power was calculated using the Barrett Universal II TK formula and used for power selection in this arm.
ARGOS (Movu/Santec; distributed by Alcon)Device
Preoperative biometric measurement using the ARGOS (software version A2.4). IOL power was calculated using the Barrett Universal II K formula and used for power selection in this arm.
| Study group | Role | What they receive |
|---|---|---|
| IOLMaster 700 | Active comparator | Patients allocated to this arm underwent biometric measurement with the IOLMaster 700 swept-source OCT biometer (Carl Zeiss Meditec AG). IOL power for the implanted TECNIS Monofocal one-piece IOL (model GCB00V) was calculated using the Barrett Universal II formula with total keratometry input (Barrett UII TK Receives: Device: IOLMaster 700 (Carl Zeiss Meditec AG) |
| ARGOS | Experimental | Patients allocated to this arm underwent biometric measurement with the ARGOS swept-source OCT biometer, which uses segmental refractive indices for axial length measurement. IOL power for the implanted TECNIS Monofocal one-piece IOL (model GCB00V) was calculated using the standard Barrett Universal II formula with anterior keratometry input (Barrett UII K Receives: Device: ARGOS (Movu/Santec; distributed by Alcon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absolute prediction error
Mean absolute prediction error determining by the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction (manifest) from both devices (IOLMaster 700 and Argos)
Measured: 4 weeks
Secondary outcomes (3)
Proportion of eyes with absolute prediction error ≤ 0.25 D
Percentage of eyes in which the absolute prediction error (|measured SE - predicted SE|) was within ±0.25 D of the target refraction at one month postoperatively, for each device-formula pairing.
Measured: 4 weeks
Median absolute prediction error
Median of the absolute differences between predicted spherical equivalent refraction (derived from preoperative biometry and IOL formula) and the actual measured spherical equivalent (manifest refraction) at one month postoperatively, for both devices (IOLMaster 700 with Barrett UII TK and ARGOS with Barrett UII K)
Measured: 4 weeks
Proportion of eyes within ±0.50 D of target refraction
Percentage of eyes in which the absolute prediction error was within ±0.50 D of the target refraction at one month postoperatively, for each device-formula pairing.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 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, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walailak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377007
- Sponsor's protocol ID
- WU66290
- Other IDs
- WU66290
- Acronym
- ORION
- Status last verified
- May 2026
- First submitted
- 30 Jan 2024
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION): A Non-Inferiority Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT06377007
- Acronym / sponsor ID
- ORION / WU66290
- Conditions
- Cataract
- Keywords
- Biometry, SS-OCT, IOLMaster700, Argos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Walailak UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 22 Apr 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.
This prospective, single-centre, randomized, parallel-group comparative clinical study evaluated the refractive prediction accuracy of two swept-source optical coherence tomography (SS-OCT) biometers in a Thai cataract surgery cohort. The ARGOS biometer applies segmental refractive indices to individual ocular segments, whereas the IOLMaster 700 applies an equivalent refractive index to the whole eye. Each device is conventionally paired with a different keratometry-formula combination: ARGOS with the standard Barrett Universal II (Barrett UII K), and IOLMaster 700 with the Barrett Universal II using total keratometry (Barrett UII TK). The study compared these two device-formula pairings as they are used in routine clinical practice. Both biometers were performed on every eye on the same day, enabling a within-subject paired comparison of biometric agreement and refractive prediction error at one month after phacoemulsification cataract surgery with implantation of a TECNIS Monofocal one-piece IOL (model GCB00V)
Detailed description
One hundred and forty-four eyes of 144 consecutive Thai cataract surgery patients aged 40-90 years presenting with visually significant age-related cataract were enrolled at the Ophthalmology Service, Walailak University Hospital between May 2024 and December 2024. Participants underwent preoperative biometric measurement on the same day with both the ARGOS (software version A2.4; Movu, Inc., a Santec company; distributed by Alcon Laboratories) and the IOLMaster 700 (software version 1.90.10; Carl Zeiss Meditec AG) by a single experienced operator. Participants were randomized 1:1 between two IOL-selection arms using a computer-generated allocation sequence (Research Randomizer, blocks of 12): Group 1 used the IOLMaster 700 with the Barrett Universal II TK formula for IOL power selection, and Group 2 used the ARGOS with the standard Barrett Universal II K formula. Allocation was concealed from the enrolling surgeon until completion of preoperative biometry. Participants were masked to the device-formula arm. All cataract surgeries were performed by four experienced surgeons (in approximately equal numbers) using a standardized phacoemulsification technique with in-the-bag implantation of the TECNIS Monofocal one-piece IOL (model GCB00V; Johnson \& Johnson Vision). The primary outcome was mean absolute prediction error (MAE) at one month postoperatively, assessed by a masked refractionist using subjective manifest refraction. Secondary outcomes were median absolute prediction error and the proportion of eyes within ±0.25 D and ±0.50 D of target refraction. One eye per patient was enrolled. The study was registered prospectively as a non-inferiority trial; the implemented analysis is reported as a within-subject paired comparative analysis with descriptive accuracy thresholds rather than as a formal non-inferiority hypothesis test (CONSORT item 3b). The total enrolled sample was 144 patients; within-subject paired analyses included 138 eyes with complete data for both devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOLMaster 700 | Active comparator | Device: IOLMaster 700 (Carl Zeiss Meditec AG)Patients allocated to this arm underwent biometric measurement with the IOLMaster 700 swept-source OCT biometer (Carl Zeiss Meditec AG). IOL power for the implanted TECNIS Monofocal one-piece IOL (model GCB00V) was calculated using the Barrett Universal II formula with total keratometry input (Barrett UII TK |
| ARGOS | Experimental | Device: ARGOS (Movu/Santec; distributed by Alcon)Patients allocated to this arm underwent biometric measurement with the ARGOS swept-source OCT biometer, which uses segmental refractive indices for axial length measurement. IOL power for the implanted TECNIS Monofocal one-piece IOL (model GCB00V) was calculated using the standard Barrett Universal II formula with anterior keratometry input (Barrett UII K |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 40-90 years presenting with visually significant age-related cataract scheduled for elective phacoemulsification with implantation of a TECNIS Monofocal one-piece IOL (model GCB00V).
Key exclusion criteria (10 listed)
- Corneal astigmatism greater than 1.00 D on either device
- Central corneal thickness outside 490-600 µm
- Severe dry eye precluding reliable keratometry
- Rigid or soft contact lens wear within 2 months prior to evaluation
- Previous corneal refractive surgery or other corneal pathology
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 |
|---|---|---|
| IOLMaster 700 (Carl Zeiss Meditec AG)Preoperative biometric measurement using the IOLMaster 700 (software version 1.90.10). IOL power was calculated using the Barrett Universal II TK formula and used for power selection in this arm. | Device | IOLMaster 700 |
| ARGOS (Movu/Santec; distributed by Alcon)Preoperative biometric measurement using the ARGOS (software version A2.4). IOL power was calculated using the Barrett Universal II K formula and used for power selection in this arm. | Device | ARGOS |
Primary outcome
Mean absolute prediction error
Time frame: 4 weeks
Mean absolute prediction error determining by the absolute disparity between the predicted spherical equivalent refraction derived from preoperative planning and the actual measured spherical equivalent refraction (manifest) from both devices (IOLMaster 700 and Argos)
3 secondary outcomes
Proportion of eyes with absolute prediction error ≤ 0.25 D
Time frame: 4 weeks
Median absolute prediction error
Time frame: 4 weeks
Proportion of eyes within ±0.50 D of target refraction
Time frame: 4 weeks
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 15 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOLMaster 700 (Carl Zeiss Meditec AG) and ARGOS (Movu/Santec; distributed by Alcon) in people with Cataract, run by Walailak University at 1 site in Thailand.
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 10 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 15 May 2026. 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 Thailand. 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?
Mean absolute prediction error (time frame: 4 weeks). 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 15 May 2026.