NCT07183891

Brief Summary

We conducted a single-center, retrospective observational study to evaluate large language models (ChatGPT 4o, GPT-5, DeepSeek) for automated interpretation of de-identified IOLMaster 700 reports provided as raster images. Models produced structured biometric extraction, toric IOL recommendation, and refractive predictions (sphere, cylinder, axis). Primary outcomes included parameter-level agreement and refractive error metrics; secondary outcomes included decision-support performance for toric IOL selection and agreement on ordered T-codes. No clinical intervention was performed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
118mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Aug 2025Dec 2035

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

5.4 years

First QC Date

September 14, 2025

Last Update Submit

September 14, 2025

Conditions

Keywords

cataracttoric IOLastigmatism

Outcome Measures

Primary Outcomes (2)

  • Refractive prediction error for sphere

    Mean absolute error (MAE, diopters) of model-predicted sphere versus clinical reference

    At index examination

  • Cohen's kappa with 95% CIs between model

    Cohen's kappa with 95% CIs between model outputs and clinician-validated reference for per-parameter

    At index examination (single time point)

Secondary Outcomes (2)

  • Cylinder prediction error

    At index examination

  • Axis prediction error

    At index examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cataract patients who had undergone phacoemulsification and implantation of an AcrySof IQ Toric monofocal intraocular lens

You may qualify if:

  • postoperative corrected distance visual acuity (CDVA) of 0.10 logMAR or better -an absolute IOL rotational stability of less than 10∘ at the 1-month follow-up examination

You may not qualify if:

  • incomplete biometric data on the examination report;
  • a history of previous ocular surgery or ocular trauma
  • the occurrence of intraoperative complications, such as an anterior capsular tear or posterior capsular rupture
  • the development of significant postoperative complications, including but not limited to severe intraocular infection or inadequate pupillary dilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 14, 2025

First Posted

September 19, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2035

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations