IOL Power Formula Prediction Accuracy at the Extremes of Axial Length: A Prospective Outcome Veri… (NCT07724795) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
IOL Power Formula Prediction Accuracy at the Extremes of Axial Length: A Prospective Outcome Verification Study
Austria200 participantsStarted 2026-08-01
Plain-language summary
This single-center, prospective, cross-sectional study evaluates how accurately eight modern intraocular lens (IOL) power calculation formulas predicted the postoperative refractive result in eyes with extreme axial length after cataract surgery. Patients previously operated at the study center who had a very short (axial length \< 22.0 mm) or very long (\> 26.0 mm) eye and received a spherical monofocal IOL are invited to a single, non-invasive outcome visit. At this visit, standardized manifest refraction, optical biometry, corneal tomography, slit-lamp examination and, in long eyes, macular OCT are performed. The measured postoperative spherical equivalent is compared with the residual refraction that each of the eight formulas had predicted for the actually implanted IOL power, separately in short and long eyes. The study aims to identify which formula predicts the postoperative outcome most accurately at the extremes of axial length, where formula choice is most consequential and least well studied.
Who can participate
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See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- Participation in the retrospective IOL power formula comparison study at the extremes of axial length (pseudonymized study ID assigned; complete preoperative biometry and archived formula outputs for all eight formula pathways)
* Cataract surgery with a spherical (non-toric) IOL of one of the three reference models (HOYA Vivinex XY1, HOYA Vivinex Impress XY1-EM, or Johnson \& Johnson Tecnis 1-Piece DIB00) at the study center between January 2022 and December 2025
* Preoperative axial length below 22.0 mm (short stratum) or above 26.0 mm (long stratum), measured on IOLMaster 700
* Documented implanted IOL model and power available from the operative record
* At least 3 months since cataract surgery at the time of the outcome visit
* Written informed consent for the outcome visit, including linkage of newly acquired postoperative data with the previously collected, pseudonymized preoperative planning data
Exclusion Criteria:
* \- Interval ocular surgery on the study eye since the original cataract surgery that may affect refraction or IOL position (e.g., corneal refractive surgery, IOL exchange or repositioning, secondary IOL implantation, or any intraocular surgery). Uncomplicated YAG laser capsulotomy without IOL repositioning is not an exclusion criterion
* Implanted IOL not matching one of the three reference platforms (e.g., toric, multifocal or EDOF IOL, a different monofocal platform, or a sulcus-fixated IOL)
* Toric IOL implantation
* Acute o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Spherical equivalent prediction error (SE-PE) across eight IOL power formulas, compared within each axial length stratum
Timeframe: Single study visit, at least 3 months after cataract surgery