Introcular Lens PositionACDCNCT07210372
Axial Stability in Short and Long Eyes After Cataract Surgery
An observational study of Introcular Lens Position, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
Post operative intraocular lens position is being measured after cataract surgery in 34 patients with long and short eyes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Introcular Lens Position
- How many people
- 34 participants
- Where
- 1 siteAustria
- Study dates
- 4 Dec 2023to 10 Jan 2025
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: patients undergoing planned cataract surgery
Who may be able to join
- bilateral cataract surger
- axial eye length below 22,75mm or above 25.50mm
Who cannot join
- ocular pathologies that could lead to an unstable capsular bag
- pregnancy
- preoperative visual acuity above 1.0logMar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Operative Axial Stabilty in Short and Long Eyes After Implanation of a Clareon Intraocular Lens
Post operative intraocular lens position is being measured after cataract surgery in 34 patients with long and short eyes.
Read the detailed description
Prediction of the post-operative IOL position in long and short eyes the prediction difficult. Therefore, it is relevant to evaluate the post-operative IOL position in patients with an axial eye length outside the typical range. This study will help to improve the prediction of the post-operative refractive outcome in short and long eyes after implantation of a Clareon IOL. Therefore, three different OCT based measurements will be used (IOLMaster700, CZM; CASIA II, Tomey; SM-39, CSO), respectively. Post-operatively, these measurements will be repeated 1 hour, 1 week, and 12 weeks after surgery.
Hypothesis: Implantation of the Clareon IOL leads to a stable post-operative IOL position in short (≤22.75mm) and long (≥25.50mm) eyes.
Endpoints:
Primary Endpoint: change in anterior chamber depth (=IOL position) in mm from 1 week to 12 weeks post-operative visit for both short and long eyes (two separate analysis) (Refraction will be a secondary outcome due to its larger variability compared to ACD measurements 1)
Secondary Endpoint:
- Refractive outcome after Clareon IOL implantation at 1- and 12-week visit o
- Monocular BCDVA and DCIVA (66cm) at 1 week and 12-week post-operative visit
- Subjects with a post operative tilt (at 12-week post operative visit) ≥10⁰ will be excluded from VA analysis
- Change in ACD in mm from 1 hour to 12 weeks, 1 hour to 1-week post-op visit for both short and long eyes Exploratory Endpoints
- Comparison of refractive outcome between long and short eyes via prediction error for Barret Universal II for long eyes and Kane formula for short eyes with target emmetropia to -2.50D based on subject's visual needs ACD in mm 1 hour, 1 week, and 12 weeks post op as measured from corneal epithelium to anterior lens surface by IOL master 700, Casia II, and MS 39
Principal Objective: Aim of this study is to measure the change in the post-operative Anterior Chamber Depth of the Clareon monofocal IOL in short/long eyed patients at different post operative time points (1 hour, 1 week, and 12 weeks) during uneventful FLACS cataract surgery.
- Exploratory/secondary Objectives:
- To measure post-operative monocular corrected visual acuity of the Clareon IOL at distance and intermediate vision (66cm)
- To Compare refractive outcomes between long and short eyes
- Conditions
- Introcular Lens Position
- Keywords
- intraocular lens position, lens position, axial length, short eye, long eye, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| short eye | patients with eye length up to 22,75mm | |
| long eye | patients with eye length at least 25,50mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in anterior chamber depth
change in anterior chamber depth in millimeter
Measured: 1 week and 12 weeks post operative
Secondary outcomes (1)
refractive outcome after intraocular lens implantation
spherical equivalent
Measured: 1 week and 12 weeks post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start4 Dec 2023
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Introcular Lens PositionStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Nino Hirnschall, MD, Principal investigator, Kepler Universitätsklinikum /JKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210372
- Sponsor's protocol ID
- JKU-Ophthalmology-002-ACDC
- Acronym
- ACDC
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Axial Stabilty in Short and Long Eyes After Implanation of a Clareon Intraocular Lens
- ClinicalTrials.gov ID
- NCT07210372
- Acronym / sponsor ID
- ACDC / JKU-Ophthalmology-002-ACDC
- Conditions
- Introcular Lens Position
- Keywords
- intraocular lens position, lens position, axial length, short eye, long eye, cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 7 Oct 2025 (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.
Post operative intraocular lens position is being measured after cataract surgery in 34 patients with long and short eyes.
Detailed description
Prediction of the post-operative IOL position in long and short eyes the prediction difficult. Therefore, it is relevant to evaluate the post-operative IOL position in patients with an axial eye length outside the typical range. This study will help to improve the prediction of the post-operative refractive outcome in short and long eyes after implantation of a Clareon IOL. Therefore, three different OCT based measurements will be used (IOLMaster700, CZM; CASIA II, Tomey; SM-39, CSO), respectively. Post-operatively, these measurements will be repeated 1 hour, 1 week, and 12 weeks after surgery.
Hypothesis: Implantation of the Clareon IOL leads to a stable post-operative IOL position in short (≤22.75mm) and long (≥25.50mm) eyes.
Endpoints:
Primary Endpoint: change in anterior chamber depth (=IOL position) in mm from 1 week to 12 weeks post-operative visit for both short and long eyes (two separate analysis) (Refraction will be a secondary outcome due to its larger variability compared to ACD measurements 1)
Secondary Endpoint:
- Refractive outcome after Clareon IOL implantation at 1- and 12-week visit o
- Monocular BCDVA and DCIVA (66cm) at 1 week and 12-week post-operative visit
- Subjects with a post operative tilt (at 12-week post operative visit) ≥10⁰ will be excluded from VA analysis
- Change in ACD in mm from 1 hour to 12 weeks, 1 hour to 1-week post-op visit for both short and long eyes Exploratory Endpoints
- Comparison of refractive outcome between long and short eyes via prediction error for Barret Universal II for long eyes and Kane formula for short eyes with target emmetropia to -2.50D based on subject's visual needs ACD in mm 1 hour, 1 week, and 12 weeks post op as measured from corneal epithelium to anterior lens surface by IOL master 700, Casia II, and MS 39
Principal Objective: Aim of this study is to measure the change in the post-operative Anterior Chamber Depth of the Clareon monofocal IOL in short/long eyed patients at different post operative time points (1 hour, 1 week, and 12 weeks) during uneventful FLACS cataract surgery.
- Exploratory/secondary Objectives:
- To measure post-operative monocular corrected visual acuity of the Clareon IOL at distance and intermediate vision (66cm)
- To Compare refractive outcomes between long and short eyes
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short eye | – | –patients with eye length up to 22,75mm |
| long eye | – | –patients with eye length at least 25,50mm |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients undergoing planned cataract surgery
Key inclusion criteria (2 listed)
- bilateral cataract surger
- axial eye length below 22,75mm or above 25.50mm
Key exclusion criteria (3 listed)
- ocular pathologies that could lead to an unstable capsular bag
- pregnancy
- preoperative visual acuity above 1.0logMar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in anterior chamber depth
Time frame: 1 week and 12 weeks post operative
change in anterior chamber depth in millimeter
1 secondary outcome
refractive outcome after intraocular lens implantation
Time frame: 1 week and 12 weeks post operative
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 7 Oct 2025.
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.
Nino Hirnschall, MD principal investigator
Kepler Universitätsklinikum /JKU
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 Introcular Lens Position, run by Johannes Kepler University of Linz at 1 site in Austria.
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 3 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 7 Oct 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 Austria. 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?
change in anterior chamber depth (time frame: 1 week and 12 weeks post operative). 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 7 Oct 2025.