Trial · NCT07891897
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
NCT07891897, Not applicable, Not yet recruiting, Zhongshan Ophthalmic Center, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction. Trials, record NCT07891897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
- NCT number
- NCT07891897
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 508 participants, estimated
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Conditions
- Refractive Errors
- Interventions
- Automated Program-Controlled Subjective Refraction, Optometrist-Performed Subjective Refraction
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Agreement in refractive prescriptions between automated and optometrist-performed subjective refraction | Day 1, after completion of both subjective refraction examinations. | Agreement between automated subjective refraction and optometrist-performed subjective refraction will be evaluated using measurements from the right eye as the primary analysis eye. The paired differences in spherical power and cylindrical power, measured in diopters (D), and cylinder axis, measured in degrees, will be analyzed using Bland-Altman analysis to estimate the mean difference (bias) and 95% limits of agreement. Intraclass correlation coefficients (ICCs) will also be calculated. The prespecified clinically acceptable limits are ±0.25 D for spherical and cylindrical power and ±5 degrees for cylinder axis. |
| Secondary | Examination time for each subjective refraction method | Day 1, during each subjective refraction examination. | The duration of each subjective refraction examination will be recorded in minutes, from the start of the refraction procedure to completion of the final refractive prescription. The paired examination durations for automated subjective refraction and optometrist-performed subjective refraction will be compared within each participant. |
| Secondary | Repeatability of the automated subjective refraction system | Day 1, after completion of both automated subjective refraction measurements | Among the first 50 adult participants who undergo two automated subjective refraction measurements, test-retest repeatability will be evaluated for spherical power and cylindrical power, measured in diopters (D), and cylinder axis, measured in degrees. Repeatability will be quantified using the intraclass correlation coefficient (ICC), within-subject standard deviation (Sw), and coefficient of repeatability. |
| Secondary | Agreement between the two subjective refraction methods under cycloplegic and non-cycloplegic conditions | Day 1, after completion of both subjective refraction examinations. | Agreement between automated subjective refraction and optometrist-performed subjective refraction will be evaluated separately in participants examined under cycloplegic conditions and those examined under non-cycloplegic conditions. Children will undergo both examinations after cycloplegia, whereas adults will undergo both examinations without cycloplegia. For each subgroup, paired differences in spherical power and cylindrical power, measured in diopters (D), and cylinder axis, measured in degrees, will be assessed using Bland-Altman analysis and intraclass correlation coefficients (ICCs). |
| Secondary | Participant acceptance, comfort, and satisfaction with the automated refraction procedure | Day 1, immediately after completion of both subjective refraction examinations. | The seven-item questionnaire assesses three aspects: understanding and operation, comfort and visual fatigue, and acceptance and willingness to use. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating a more favorable evaluation. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891897
GET https://conductscience.org/api/trials/v1/NCT07891897/registered