Age-related CataractCATARACTOMIQUENCT05802550
Metabo-lipidomics of the Ocular Surface for Cataract Surgery
A study testing Ocular Surface Disease Index, Interferometry and Oxford score in people with Age-related Cataract, run by University Hospital, Tours at 1 site in France.
Trial summary
Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- Ocular Surface Disease Index, Interferometry and Oxford score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2023to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patient with cortico-nuclear and/or subcapsular cataract
- Age > or = 50 years
- Patient affiliated to a social security system
- Patient agreeing to participate in the study who provided his/her free and informed written consent
Who cannot join
- History of ocular surgery or trauma (≤ 3 months)
- Other types of cataract excepted age-related or diabetic cataract
- Any eye drops or treatments that may interfere with the ocular surface
- Lens wearer
- Any general pathology with a known impact on the ocular surface (auto-immune disease, allergy)
- Proven allergy to povidone-iodine or to a component of the postoperative treatment
- Patient under legal protection (safeguard of justice, curatorship and guardianship), or in a situation of deprivation of freedom
- Patient unable to understand the nature and objectives of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabo-lipidomic Analysis of the Ocular Surface and Aqueous Humor for the Search of Predictive Biomarkers of Ocular Surface Disease After Cataract Surgery: a Prospective Cohort Study
Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery.
The identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care.
Read more
Conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery.
An approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery.
This study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.
- Conditions
- Age-related Cataract
- Being tested
- Ocular Surface Disease Index, Interferometry, Oxford score, Conjunctival collection, Aqueous humor collection
- Keywords
- Ocular surface, Cataract, Conjunctival impression cytology, Aqueous humor, Metabolomic, Lipidomic
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular Surface Disease IndexOther
Questionnaire on ocular surface disorders
InterferometryOther
Non-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement
Oxford scoreOther
Investigation and quantification of superficial corneal punctate keratitis using the Oxford score
Conjunctival collectionOther
Two conjunctival prints: one for metabolomic and one for lipidomic
Aqueous humor collectionOther
Collection of 0.1 mL of aqueous humor immediately after making the accessory corneal incision at the beginning of the cataract surgery.
Quantification of Tyndall and flareOther
Quantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal cohort study in cataract patients | Other | Longitudinal, open-label, single-center cohort study in cataract patients. Receives: Other: Ocular Surface Disease Index; Other: Interferometry; Other: Oxford score; Other: Conjunctival collection; Other: Aqueous humor collection; Other: Quantification of Tyndall and flare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ocular surface disease
Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 1 month following cataract surgery.
Measured: 1 months after cataract surgery
Postoperative ocular surface disease
Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 3 months following cataract surgery.
Measured: 3 months after cataract surgery
Secondary outcomes (2)
Change in number and semi-quantitative concentrations of ocular surface metabolites
Comparison of ocular surface metabolome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
Measured: From baseline to 1 month after cataract surgery
Change in number and semi-quantitative concentrations of ocular surface lipids
Comparison of ocular surface lipidome using conjunctival impression cytology pre and postoperatively 1 month after cataract surgery
Measured: From baseline to 1 month after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start4 Sep 2023
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related CataractStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802550
- Sponsor's protocol ID
- DR220231
- Acronym
- CATARACTOMIQUE
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabo-lipidomic Analysis of the Ocular Surface and Aqueous Humor for the Search of Predictive Biomarkers of Ocular Surface Disease After Cataract Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05802550
- Acronym / sponsor ID
- CATARACTOMIQUE / DR220231
- Conditions
- Age-related Cataract
- Keywords
- Ocular surface, Cataract, Conjunctival impression cytology, Aqueous humor, Metabolomic, Lipidomic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 6 Apr 2023 (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.
Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery.
The identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care.
Conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery.
An approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery.
This study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal cohort study in cataract patients | Other | Other: Ocular Surface Disease Index, Other: Interferometry, Other: Oxford score, Other: Conjunctival collection, Other: Aqueous humor collection, Other: Quantification of Tyndall and flareLongitudinal, open-label, single-center cohort study in cataract patients. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with cortico-nuclear and/or subcapsular cataract
- Age > or = 50 years
- Patient affiliated to a social security system
- Patient agreeing to participate in the study who provided his/her free and informed written consent
Key exclusion criteria (8 listed)
- History of ocular surgery or trauma (≤ 3 months)
- Other types of cataract excepted age-related or diabetic cataract
- Any eye drops or treatments that may interfere with the ocular surface
- Lens wearer
- Any general pathology with a known impact on the ocular surface (auto-immune disease, allergy)
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 |
|---|---|---|
| Ocular Surface Disease IndexQuestionnaire on ocular surface disorders | Other | Longitudinal cohort study in cataract patients |
| InterferometryNon-contact examination measuring NIBUT (non-invasive break-up time), meibography and tear meniscus measurement | Other | Longitudinal cohort study in cataract patients |
| Oxford scoreInvestigation and quantification of superficial corneal punctate keratitis using the Oxford score | Other | Longitudinal cohort study in cataract patients |
| Conjunctival collectionTwo conjunctival prints: one for metabolomic and one for lipidomic | Other | Longitudinal cohort study in cataract patients |
| Aqueous humor collectionCollection of 0.1 mL of aqueous humor immediately after making the accessory corneal incision at the beginning of the cataract surgery. | Other | Longitudinal cohort study in cataract patients |
| Quantification of Tyndall and flareQuantification of Tyndall and flare (from 1 to 4 crosses) in anterior chamber | Other | Longitudinal cohort study in cataract patients |
Primary outcome
Postoperative ocular surface disease
Time frame: 1 months after cataract surgery
Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 1 month following cataract surgery.
Postoperative ocular surface disease
Time frame: 3 months after cataract surgery
Metabo-lipidomic analysis of intracellular content of the ocular surface preoperatively and aqueous humor intraoperatively to predict occurrence of ocular surface disease 3 months following cataract surgery.
2 secondary outcomes
Change in number and semi-quantitative concentrations of ocular surface metabolites
Time frame: From baseline to 1 month after cataract surgery
Change in number and semi-quantitative concentrations of ocular surface lipids
Time frame: From baseline to 1 month after cataract surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Age-related Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
Not yet recruiting
Safety and Clinical Performance of the LENTIS® MAX LS-313 MF80 Compared With the Monofocal L-313 in Cataract Patients With Late Age-Related Macular Degeneration: A Multicenter Comparative Clinical Investigation.
Cataract, AMD - Age-Related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Recruiting
Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice
Vision Impairment and Blindness, Glaucoma
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Age Related Cataracts
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?
A study testing Ocular Surface Disease Index, Interferometry and Oxford score in people with Age-related Cataract, run by University Hospital, Tours 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: finished, as of the sponsor's last update on 13 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative ocular surface disease (time frame: 1 months after cataract surgery). The study lists 2 primary outcomes in all. 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 13 Feb 2026.