Lens DiseasesNCT07741370
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
An observational study of Lens Diseases and Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This multicenter retrospective study will collect clinical data to investigate the associations between preoperative and intraoperative anterior segment structural changes and postoperative surgical outcomes in patients with lens disorders, and to evaluate the clinical benefits of intraoperative optical coherence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lens Diseases, Cataract, Age-related Cataract
- What is being tested?
- Intraoperative Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years or older who underwent lens surgery for lens opacity or abnormal lens position between March 1, 2024 and March 1, 2026 at the participating hospitals. Eligible surgical eyes will be identified retrospectively from medical records and classified according to whether intraoperative optical coherence tomography was used during surgery.
Who may be able to join
- Aged 18 years or older.
- Presence of lens opacity or abnormal lens position.
- Visual impairment affecting activities of daily living.
- Met the indications for lens surgery.
- Underwent lens surgery.
Who cannot join
- Active intraocular inflammation.
- Uncontrolled systemic disease, use of medications that could significantly affect surgery, or other standard contraindications to lens surgery.
- Incomplete or unreliable key preoperative examination data, including ocular biometry.
- Inadequate image quality due to poor fixation or other causes, rendering the images unsuitable for analysis.
- Incomplete intraoperative OCT recordings, such as interrupted recording or severe image freezing, affecting data evaluation.
- Other psychological or physical conditions that might interfere with study participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Multicenter Study on the Use of Intraoperative Optical Coherence Tomography in the Diagnosis and Management of Lens Diseases
This multicenter retrospective study will collect clinical data to investigate the associations between preoperative and intraoperative anterior segment structural changes and postoperative surgical outcomes in patients with lens disorders, and to evaluate the clinical benefits of intraoperative optical coherence tomography (iOCT) in lens surgery, with the aim of improving the diagnosis and treatment of lens-related diseases.
Read the detailed description
Lens disorders, particularly cataract, are a leading cause of blindness worldwide and substantially impair quality of life. Surgery remains the most effective treatment, but pre-existing abnormalities of the lens and adjacent ocular structures, together with unexpected intraoperative events, may increase surgical complexity and affect outcomes. Accurate assessment of anterior segment structures is therefore essential, as abnormalities caused by trauma, congenital disorders, ocular diseases, or systemic conditions may involve the lens, capsule, cornea, iris, or anterior chamber angle. Even during routine phacoemulsification, variations in irrigation pressure, anterior chamber depth, capsular bag integrity, capsular expansion, and residual cortex may influence surgical safety, IOL centration, and postoperative refractive stability. Because some abnormalities cannot be reliably detected preoperatively, intraoperative optical coherence tomography (iOCT) may provide real-time structural information and support surgical decision-making. However, evidence regarding its effects on surgical strategy, visual outcomes, refractive stability, and complications remains limited. This multicenter retrospective study will assess the associations between preoperative and intraoperative anterior segment changes and postoperative outcomes, and evaluate the clinical value of iOCT in lens surgery.
- Being tested
- Intraoperative Optical Coherence Tomography
- Keywords
- Intraoperative Optical Coherence Tomography, Lens Diseases
- Medical subject headings
- Lens Diseases, Cataract, Capsule Opacification, Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Optical Coherence TomographyDevice
Intraoperative optical coherence tomography technique can provide intraocular images and show changes in intraocular structures, assisting in analyzing the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Microscopy Cohort | Patients who underwent lens surgery using conventional surgical microscopy without intraoperative OCT. | |
| Intraoperative OCT-Assisted Surgery Cohort | Patients who underwent lens surgery using conventional surgical microscopy with intraoperative OCT assistance. Receives: Device: Intraoperative Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance Rate Between Preoperative and Intraoperative Diagnoses
Preoperative diagnoses are determined based on routine ophthalmic examinations. Intraoperative diagnoses are determined based on surgical microscopic observations, intraoperative OCT images, and operative records. Concordance between the preoperative and intraoperative diagnoses is assessed, including whether the intraoperative diagnosis adds to or corrects the preoperative diagnosis.
Measured: From completion of the preoperative examinations through the end of surgery; diagnostic concordance is assessed after surgery.
Secondary outcomes (2)
Intraocular Lens Tilt Angle
The tilt angle of the implanted intraocular lens is measured on intraoperative OCT images using a standardized image analysis protocol. A predefined ocular-axis reference line is used to calculate the angle between the intraocular lens axis and the reference axis.
Measured: After intraocular lens implantation and at the end of surgery.
Incidence of Intraoperative Complications
Intraoperative complications are identified from operative records and intraoperative imaging. The incidence of each complication is calculated.
Measured: From the start to the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Mar 2024
- Primary completion1 Mar 2026
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Fourth Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, People's Hospital of Ningxia Hui Autonomous Region
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741370
- Sponsor's protocol ID
- 2026-0218
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on the Use of Intraoperative Optical Coherence Tomography in the Diagnosis and Management of Lens Diseases
- ClinicalTrials.gov ID
- NCT07741370
- Acronym / sponsor ID
- 2026-0218
- Keywords
- Intraoperative Optical Coherence Tomography, Lens Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Fourth Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, People's Hospital of Ningxia Hui Autonomous Region
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 3 Aug 2026 (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 multicenter retrospective study will collect clinical data to investigate the associations between preoperative and intraoperative anterior segment structural changes and postoperative surgical outcomes in patients with lens disorders, and to evaluate the clinical benefits of intraoperative optical coherence tomography (iOCT) in lens surgery, with the aim of improving the diagnosis and treatment of lens-related diseases.
Detailed description
Lens disorders, particularly cataract, are a leading cause of blindness worldwide and substantially impair quality of life. Surgery remains the most effective treatment, but pre-existing abnormalities of the lens and adjacent ocular structures, together with unexpected intraoperative events, may increase surgical complexity and affect outcomes. Accurate assessment of anterior segment structures is therefore essential, as abnormalities caused by trauma, congenital disorders, ocular diseases, or systemic conditions may involve the lens, capsule, cornea, iris, or anterior chamber angle. Even during routine phacoemulsification, variations in irrigation pressure, anterior chamber depth, capsular bag integrity, capsular expansion, and residual cortex may influence surgical safety, IOL centration, and postoperative refractive stability. Because some abnormalities cannot be reliably detected preoperatively, intraoperative optical coherence tomography (iOCT) may provide real-time structural information and support surgical decision-making. However, evidence regarding its effects on surgical strategy, visual outcomes, refractive stability, and complications remains limited. This multicenter retrospective study will assess the associations between preoperative and intraoperative anterior segment changes and postoperative outcomes, and evaluate the clinical value of iOCT in lens surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Microscopy Cohort | – | –Patients who underwent lens surgery using conventional surgical microscopy without intraoperative OCT. |
| Intraoperative OCT-Assisted Surgery Cohort | – | Device: Intraoperative Optical Coherence TomographyPatients who underwent lens surgery using conventional surgical microscopy with intraoperative OCT assistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older who underwent lens surgery for lens opacity or abnormal lens position between March 1, 2024 and March 1, 2026 at the participating hospitals. Eligible surgical eyes will be identified retrospectively from medical records and classified according to whether intraoperative optical coherence tomography was used during surgery.
Key inclusion criteria (5 listed)
- Aged 18 years or older.
- Presence of lens opacity or abnormal lens position.
- Visual impairment affecting activities of daily living.
- Met the indications for lens surgery.
- Underwent lens surgery.
Key exclusion criteria (6 listed)
- Active intraocular inflammation.
- Uncontrolled systemic disease, use of medications that could significantly affect surgery, or other standard contraindications to lens surgery.
- Incomplete or unreliable key preoperative examination data, including ocular biometry.
- Inadequate image quality due to poor fixation or other causes, rendering the images unsuitable for analysis.
- Incomplete intraoperative OCT recordings, such as interrupted recording or severe image freezing, affecting data evaluation.
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 |
|---|---|---|
| Intraoperative Optical Coherence TomographyIntraoperative optical coherence tomography technique can provide intraocular images and show changes in intraocular structures, assisting in analyzing the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases. | Device | Intraoperative OCT-Assisted Surgery Cohort |
Primary outcome
Concordance Rate Between Preoperative and Intraoperative Diagnoses
Time frame: From completion of the preoperative examinations through the end of surgery; diagnostic concordance is assessed after surgery.
Preoperative diagnoses are determined based on routine ophthalmic examinations. Intraoperative diagnoses are determined based on surgical microscopic observations, intraoperative OCT images, and operative records. Concordance between the preoperative and intraoperative diagnoses is assessed, including whether the intraoperative diagnosis adds to or corrects the preoperative diagnosis.
2 secondary outcomes
Intraocular Lens Tilt Angle
Time frame: After intraocular lens implantation and at the end of surgery.
Incidence of Intraoperative Complications
Time frame: From the start to the end of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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?
An observational study of Lens Diseases and Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Concordance Rate Between Preoperative and Intraoperative Diagnoses (time frame: From completion of the preoperative examinations through the end of surgery; diagnostic concordance is assessed after surgery.). 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 5 Aug 2026.