Vitreous DetachmentVitCatNCT07816887
Evaluation of Vitreous Modifications After Cataract Surgery
An observational study of Vitreous Detachment and Cataract (Post-operative Cataract Surgery Follow-up), run by University of Trieste at 1 site in France.
Trial summary
This study aims to evaluate changes in vitreous structure and the vitreoretinal interface following cataract surgery using spectral-domain optical coherence tomography (OCT). Patients undergoing cataract surgery will undergo standardized OCT imaging before and after surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vitreous Detachment, Cataract (Post-operative Cataract Surgery Follow-up)
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2026to 20 Oct 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for cataract surgery without posterior vitreous detachment
Who may be able to join
- Presence of cataract scheduled for surgery
- Adequate image acquisition quality
- Absence of posterior vitreous detachment (PVD)
- Availability of both preoperative and postoperative OCT imaging
Who cannot join
- Advanced cataract significantly compromising image quality
- Presence of posterior vitreous detachment (PVD)
- History of vitreous hemorrhage
- Previous vitreoretinal surgery
- Previous intravitreal injections (IVT)
- Retinal diseases affecting vitreoretinal interface assessment
- Pathologic high myopia
- History of ocular trauma or uveitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, Paris, 94000
Marco Pastore, MD, PhD, +33 (0) 1 57 02 30 54, marco.pastore@chicreteil.fr
About this study
Official title: Assessment of Vitreous Changes Following Cataract Surgery
This study aims to evaluate changes in vitreous structure and the vitreoretinal interface following cataract surgery using spectral-domain optical coherence tomography (OCT). Patients undergoing cataract surgery will undergo standardized OCT imaging before and after surgery. Preoperative and postoperative images will be compared to identify and characterize qualitative and quantitative changes in vitreous morphology, with particular attention to the posterior vitreous and its relationship with the retinal surface.
Read the detailed description
Cataract surgery may induce anatomical and biomechanical changes within the vitreous body and at the vitreoretinal interface. However, the extent and characteristics of these modifications remain incompletely defined, particularly when assessed using high-resolution optical coherence tomography (OCT).
The aim of this study is to investigate structural changes in the vitreous and vitreoretinal interface occurring after cataract surgery through a standardized preoperative and postoperative spectral-domain OCT imaging protocol.
Patients with cataract scheduled for surgery will be considered for inclusion. Eligible participants must have OCT images of sufficient quality for reliable assessment and no evidence of posterior vitreous detachment (PVD) at baseline. Both preoperative and postoperative OCT imaging must be available for comparative analysis.
Standardized OCT acquisition will include the 18 Line R64 and AS Star 18 Line R16 imaging protocols using the Dream OCT platform. These scans will be used to assess the posterior vitreous, its relationship with the retinal surface, and any postoperative changes in vitreous morphology or vitreoretinal interface configuration.
Preoperative and postoperative images will be compared both qualitatively and quantitatively. The analysis will focus on identifying changes in the visibility, configuration, position, and attachment of the posterior vitreous structures, as well as any modifications of the vitreoretinal interface occurring following cataract surgery.
Patients will be excluded in the presence of factors that may interfere with accurate vitreous assessment or independently alter vitreoretinal anatomy. These include advanced cataract significantly compromising OCT image quality, pre-existing posterior vitreous detachment, previous vitreous hemorrhage, previous vitreoretinal surgery, prior intravitreal injections, retinal diseases affecting evaluation of the vitreoretinal interface, pathologic high myopia, and a history of ocular trauma or uveitis.
The primary objective is to quantitatively and qualitatively characterize postoperative changes in vitreous morphology and vitreoretinal interface features after cataract surgery. The study is intended to improve understanding of the early structural effects of cataract surgery on the vitreous and to determine whether OCT imaging can reliably document these postoperative modifications.
- Being tested
- cataract surgery
- Keywords
- vitreous detachment, post-operative cataracte surgery
- Medical subject headings
- Vitreous Detachment, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
standard cataracte surgery
| Study group | Role | What they receive |
|---|---|---|
| No vitreous detachment | Patients scheduled for cataract surgery without posterior vitreous detachment Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration
Preoperative and postoperative OCT images will be compared to identify participants showing structural changes in the posterior vitreous or vitreoretinal interface, including changes in posterior hyaloid position, vitreoretinal attachment status, and the development of partial or complete posterior vitreous detachment (PVD). Results will be reported as the number and proportion of participants presenting these postoperative changes.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Jul 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreous DetachmentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Rocco Pastore, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816887
- Sponsor's protocol ID
- 05072026
- Acronym
- VitCat
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data are not planned to be publicly shared. However, fully anonymized data may be considered for sharing with qualified researchers upon reasonable request, subject to applicable ethical, institutional, and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vitreous Changes Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT07816887
- Acronym / sponsor ID
- VitCat / 05072026
- Keywords
- vitreous detachment, post-operative cataracte surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 14 Sep 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 study aims to evaluate changes in vitreous structure and the vitreoretinal interface following cataract surgery using spectral-domain optical coherence tomography (OCT). Patients undergoing cataract surgery will undergo standardized OCT imaging before and after surgery. Preoperative and postoperative images will be compared to identify and characterize qualitative and quantitative changes in vitreous morphology, with particular attention to the posterior vitreous and its relationship with the retinal surface.
Detailed description
Cataract surgery may induce anatomical and biomechanical changes within the vitreous body and at the vitreoretinal interface. However, the extent and characteristics of these modifications remain incompletely defined, particularly when assessed using high-resolution optical coherence tomography (OCT).
The aim of this study is to investigate structural changes in the vitreous and vitreoretinal interface occurring after cataract surgery through a standardized preoperative and postoperative spectral-domain OCT imaging protocol.
Patients with cataract scheduled for surgery will be considered for inclusion. Eligible participants must have OCT images of sufficient quality for reliable assessment and no evidence of posterior vitreous detachment (PVD) at baseline. Both preoperative and postoperative OCT imaging must be available for comparative analysis.
Standardized OCT acquisition will include the 18 Line R64 and AS Star 18 Line R16 imaging protocols using the Dream OCT platform. These scans will be used to assess the posterior vitreous, its relationship with the retinal surface, and any postoperative changes in vitreous morphology or vitreoretinal interface configuration.
Preoperative and postoperative images will be compared both qualitatively and quantitatively. The analysis will focus on identifying changes in the visibility, configuration, position, and attachment of the posterior vitreous structures, as well as any modifications of the vitreoretinal interface occurring following cataract surgery.
Patients will be excluded in the presence of factors that may interfere with accurate vitreous assessment or independently alter vitreoretinal anatomy. These include advanced cataract significantly compromising OCT image quality, pre-existing posterior vitreous detachment, previous vitreous hemorrhage, previous vitreoretinal surgery, prior intravitreal injections, retinal diseases affecting evaluation of the vitreoretinal interface, pathologic high myopia, and a history of ocular trauma or uveitis.
The primary objective is to quantitatively and qualitatively characterize postoperative changes in vitreous morphology and vitreoretinal interface features after cataract surgery. The study is intended to improve understanding of the early structural effects of cataract surgery on the vitreous and to determine whether OCT imaging can reliably document these postoperative modifications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No vitreous detachment | – | Procedure: cataract surgeryPatients scheduled for cataract surgery without posterior vitreous detachment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for cataract surgery without posterior vitreous detachment
Key inclusion criteria (4 listed)
- Presence of cataract scheduled for surgery
- Adequate image acquisition quality
- Absence of posterior vitreous detachment (PVD)
- Availability of both preoperative and postoperative OCT imaging
Key exclusion criteria (8 listed)
- Advanced cataract significantly compromising image quality
- Presence of posterior vitreous detachment (PVD)
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 |
|---|---|---|
| cataract surgerystandard cataracte surgery | Procedure or surgery | No vitreous detachment |
Primary outcome
Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration
Time frame: 4 weeks
Preoperative and postoperative OCT images will be compared to identify participants showing structural changes in the posterior vitreous or vitreoretinal interface, including changes in posterior hyaloid position, vitreoretinal attachment status, and the development of partial or complete posterior vitreous detachment (PVD). Results will be reported as the number and proportion of participants presenting these postoperative changes.
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 14 Sep 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data are not planned to be publicly shared. However, fully anonymized data may be considered for sharing with qualified researchers upon reasonable request, subject to applicable ethical, institutional, and data protection requirements.
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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.
Centre Hospitalier Intercommunal de Créteil
Créteil, France
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 Vitreous Detachment and Cataract (Post-operative Cataract Surgery Follow-up), run by University of Trieste at 1 site in France.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Sep 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 France. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Changes in Vitreous Morphology or Vitreoretinal Interface Configuration (time frame: 4 weeks). 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 14 Sep 2026.