Dry Eye Disease (DED)NCT06989827
Impact of DED on the Accuracy of Preoperative Keratometry Values in the Calculation of IOL Power for Cataract Surgery.
A study testing Preservative free artificial tear in people with Dry Eye Disease (DED) and Cataract, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
Trial summary
This study looks at how dry eye disease can affect important eye measurements needed before cataract surgery. These measurements guide us in choosing the right artificial lens to implant, which is essential for achieving clear vision after the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED), Cataract
- What is being tested?
- Preservative free artificial tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 2 Jun 2025to Mar 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy controls scheduled to undergo cataract surgery
- patients diagnosed with dry eye disease scheduled to undergo cataract surgery
Who cannot join
- patients already on therapy regimen using Preservative free artificial tears
- patients on antihistamines/decongestants, antidepressants, anti-Parkinson's, antipsychotics and antispasmodic medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
UHC Sestre Milosrdnice
Zagreb, City of Zagreb, 10000
Stjepan Pinotić, MD, +385977493252, spinotic@gmail.com
About this study
Official title: Evaluation of the Influence of Dry Eye Disease on the Precision of Preoperative Keratometry Measurements and Its Effect on Intraocular Lens Power Calculations in Patients Undergoing Cataract Surgery.
This study looks at how dry eye disease can affect important eye measurements needed before cataract surgery. These measurements guide us in choosing the right artificial lens to implant, which is essential for achieving clear vision after the procedure. We are currently investigating whether patients with dry eyes tend to have less reliable readings due to surface irregularities on the eye. Our goal is to better understand this connection so we can improve pre-surgical preparation for patients with dry eye and help ensure better visual outcomes after cataract surgery.
Read the detailed description
In this study, we are investigating the potential impact of dry eye disease (DED) on the accuracy of preoperative keratometry values used in intraocular lens (IOL) power calculations for cataract surgery. Precise keratometric measurements are essential for determining the appropriate IOL power to achieve optimal postoperative refractive outcomes. However, ocular surface irregularities associated with DED-such as tear film instability, corneal epithelial disruption, and increased surface variability-may compromise the repeatability and reliability of these measurements.
We aim to examine the correlation between the severity of dry eye and the variability or inaccuracy in keratometric readings obtained through standard biometry techniques. Patients undergoing cataract surgery are being prospectively evaluated and stratified based on dry eye status using established diagnostic criteria, including patient-reported symptom questionnaires (OSDI), tear break-up time (TBUT), corneal staining patterns (Oxford grading scale), Schirmer's test values, and Meibomian Gland Evaluation (Meibomian Quality Score). Preoperative keratometry data are collected using optical biometers, and repeated measurements are analyzed for variability. IOL power calculations are compared with postoperative refractive outcomes to assess clinical significance.
By identifying potential discrepancies linked to dry eye severity, we aim to determine whether preoperative DED management could meaningfully improve measurement precision and, consequently, visual outcomes. Preliminary observations suggest that untreated or suboptimally managed DED may lead to inconsistent keratometric values, which in turn could contribute to unexpected postoperative refractive errors.
Our ultimate goal is to provide evidence-based recommendations for preoperative screening and treatment protocols for DED in cataract surgery candidates. These findings could support the development of standardized guidelines that incorporate ocular surface optimization as an essential component of pre-surgical planning, thereby enhancing surgical precision and patient satisfaction.
- Conditions
- Dry Eye Disease (DED), Cataract
- Being tested
- Preservative free artificial tear
- Keywords
- keratometry, IOL, intraocular lens, cataract surgery, dry eye disease, DED
- Medical subject headings
- Dry Eye Syndromes, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative free artificial tearDrug
After diagnosing patients with dry eye disease we prescribed them preservative free artificial tears and scheduled them for a follow-up keratometry.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | No intervention | Not described |
| Patients with diagnosed dry eye disease | Active comparator | Not described Receives: Drug: Preservative free artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in keratometric values before and after dry eye disease treatment with preservative free artificial tears
Measured: pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start2 Jun 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed to compare two parallel groups of patients, healthy controls and patients diagnosed with dry eye disease.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stjepan Pinotić, University Hospital Sestre Milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989827
- Sponsor's protocol ID
- DED_Cataract_25
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang F, Yang L, Ning X, Liu J, Wang J. Effect of dry eye on the reliability of keratometry for cataract surgery planning. J Fr Ophtalmol. 2024 Feb;47(2):103999. doi: 10.1016/j.jfo.2023.04.016. Epub 2023 Oct 31.
PubMed 37919153
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Dry Eye Disease on the Precision of Preoperative Keratometry Measurements and Its Effect on Intraocular Lens Power Calculations in Patients Undergoing Cataract Surgery.
- ClinicalTrials.gov ID
- NCT06989827
- Acronym / sponsor ID
- DED_Cataract_25
- Conditions
- Dry Eye Disease (DED), Cataract
- Keywords
- keratometry, IOL, intraocular lens, cataract surgery, dry eye disease, DED
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 May 2025 (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 looks at how dry eye disease can affect important eye measurements needed before cataract surgery. These measurements guide us in choosing the right artificial lens to implant, which is essential for achieving clear vision after the procedure. We are currently investigating whether patients with dry eyes tend to have less reliable readings due to surface irregularities on the eye. Our goal is to better understand this connection so we can improve pre-surgical preparation for patients with dry eye and help ensure better visual outcomes after cataract surgery.
Detailed description
In this study, we are investigating the potential impact of dry eye disease (DED) on the accuracy of preoperative keratometry values used in intraocular lens (IOL) power calculations for cataract surgery. Precise keratometric measurements are essential for determining the appropriate IOL power to achieve optimal postoperative refractive outcomes. However, ocular surface irregularities associated with DED-such as tear film instability, corneal epithelial disruption, and increased surface variability-may compromise the repeatability and reliability of these measurements.
We aim to examine the correlation between the severity of dry eye and the variability or inaccuracy in keratometric readings obtained through standard biometry techniques. Patients undergoing cataract surgery are being prospectively evaluated and stratified based on dry eye status using established diagnostic criteria, including patient-reported symptom questionnaires (OSDI), tear break-up time (TBUT), corneal staining patterns (Oxford grading scale), Schirmer's test values, and Meibomian Gland Evaluation (Meibomian Quality Score). Preoperative keratometry data are collected using optical biometers, and repeated measurements are analyzed for variability. IOL power calculations are compared with postoperative refractive outcomes to assess clinical significance.
By identifying potential discrepancies linked to dry eye severity, we aim to determine whether preoperative DED management could meaningfully improve measurement precision and, consequently, visual outcomes. Preliminary observations suggest that untreated or suboptimally managed DED may lead to inconsistent keratometric values, which in turn could contribute to unexpected postoperative refractive errors.
Our ultimate goal is to provide evidence-based recommendations for preoperative screening and treatment protocols for DED in cataract surgery candidates. These findings could support the development of standardized guidelines that incorporate ocular surface optimization as an essential component of pre-surgical planning, thereby enhancing surgical precision and patient satisfaction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is designed to compare two parallel groups of patients, healthy controls and patients diagnosed with dry eye disease.
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | No intervention | – |
| Patients with diagnosed dry eye disease | Active comparator | Drug: Preservative free artificial tear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy controls scheduled to undergo cataract surgery
- patients diagnosed with dry eye disease scheduled to undergo cataract surgery
Key exclusion criteria (2 listed)
- patients already on therapy regimen using Preservative free artificial tears
- patients on antihistamines/decongestants, antidepressants, anti-Parkinson's, antipsychotics and antispasmodic medications.
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 |
|---|---|---|
| Preservative free artificial tearAfter diagnosing patients with dry eye disease we prescribed them preservative free artificial tears and scheduled them for a follow-up keratometry. | Drug | Patients with diagnosed dry eye disease |
Primary outcome
Variability in keratometric values before and after dry eye disease treatment with preservative free artificial tears
Time frame: pre-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 25 May 2025.
- Results publication: PubMed 37919153Yang F, Yang L, Ning X, Liu J, Wang J. Effect of dry eye on the reliability of keratometry for cataract surgery planning. J Fr Ophtalmol. 2024 Feb;47(2):103999. doi: 10.1016/j.jfo.2023.04.016. Epub 2023 Oct 31.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservative free artificial tear in people with Dry Eye Disease (DED) and Cataract, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 25 May 2025. 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 Croatia. 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?
Contact Stjepan Pinotić, MD (00385977493252, spinotic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in keratometric values before and after dry eye disease treatment with preservative free artificial tears (time frame: pre-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06989827, which also lists 1 linked publication.
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 25 May 2025.