CataractEyeSurfaceNCT05753787
Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
A study testing preservative-free solution of standard post-cataract eye drops in people with Cataract and Surgical Injury, run by Spektrum Center of Clinical Ophthalmology at 1 site in Poland.
Trial summary
The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface. The main question is to learn about an effect of preservatives on the eye surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Surgical Injury, Healing Wound
- What is being tested?
- preservative-free solution of standard post-cataract eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cataract surgery required defined previously by the eye-care specialist
- good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity)
- consent to the study protocol
Who cannot join
- diagnosed glaucoma
- diagnosed previous allergy
- diagnosed diabetic retinopathy or maculopathy
- previously diagnosed dry eye disease that requires treatment with multiple artificial tears
- permanent usage of the eye drops other than artificial tears
- non-compliance to the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface.
The main question is to learn about an effect of preservatives on the eye surface. The study aims to answer some important questions:
Read more
- if the usage of preservatives has an impact on the eye surface healing process after cataract surgery
- if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops.
Participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state.
Researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.
- Conditions
- Cataract, Surgical Injury, Healing Wound
- Being tested
- preservative-free solution of standard post-cataract eye drops
- Medical subject headings
- Cataract, Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preservative-free solution of standard post-cataract eye dropsOther
Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.
| Study group | Role | What they receive |
|---|---|---|
| preservatives-free dexamethasone 0.1% eye drops | Active comparator | Not described Receives: Other: preservative-free solution of standard post-cataract eye drops |
| preserved dexamethasone 0.1% eye drops | Placebo comparator | Not described Receives: Other: preservative-free solution of standard post-cataract eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity result
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
Measured: up to 21 days post-surgery
Ocular staining score result
standard staining score - a scale used with the fluorescein stain; higher value expres more severe outcome, normal values are around 0-1. Overal information can be found: https://entokey.com/a-simplified-quantitative-method-for-assessing-keratoconjunctivitis-sicca-from-the-sjogrens-syndrome-international-registry/
Measured: up to 21 days post-surgery
Ocular Surface Disease Index survey result
a standard survey that patient will preform at each visit
Measured: up to 21 days post-surgery
Secondary outcomes (5)
Fluorescein Break-up Time assessment
time to break-up the tear film after the instilation of the fluorescein eye drop (evaluated 3 fold and the mean will be taken into account)
Measured: up to 21 days post-surgery
SICCA scale assessment
Scale that requires both fluorescein and lissamine green staining profile assesment - used in the standardised manner
Measured: up to 21 days post-surgery
Shirmer test 1 measurement
test that evaluate the amount of tears (in mm on the test paper) that are produced within 5 minutes and are evaluated under the anesthesia
Measured: up to 21 days post-surgery
Intraocular pressure measurement
Intraocular pressure measurement preformed by standard tonometer
Measured: up to 21 days post-surgery
Anterior chamber cell intensity measurement
the standardised SUN assesment of the anterior chamber cell intensity will be preformed - a standardised scale
Measured: up to 21 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (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 CataractStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spektrum Center of Clinical Ophthalmology
- Sponsor type
- University, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Maria Muzyka-Woźniak, PhD, Principal investigator, Spektrum Clinic of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753787
- Sponsor's protocol ID
- Spektrum2022/01
- Acronym
- EyeSurface
- Status last verified
- Sep 2023
- First submitted
- 23 Oct 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Muzyka-Wozniak M, Strozecki L, Przezdziecka-Dolyk J. Assessment of the eye surface and subjective symptoms after using 0.1% dexamethasone drops with and without preservatives in patients after cataract surgery. Sci Rep. 2023 Oct 30;13(1):18625. doi: 10.1038/s41598-023-44939-1.
PubMed 37903818
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
- ClinicalTrials.gov ID
- NCT05753787
- Acronym / sponsor ID
- EyeSurface / Spektrum2022/01
- Conditions
- Cataract, Surgical Injury, Healing Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Spektrum Center of Clinical OphthalmologyUniversity, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Mar 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.
The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface.
The main question is to learn about an effect of preservatives on the eye surface. The study aims to answer some important questions:
- if the usage of preservatives has an impact on the eye surface healing process after cataract surgery
- if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops.
Participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state.
Researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preservatives-free dexamethasone 0.1% eye drops | Active comparator | Other: preservative-free solution of standard post-cataract eye drops |
| preserved dexamethasone 0.1% eye drops | Placebo comparator | Other: preservative-free solution of standard post-cataract eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cataract surgery required defined previously by the eye-care specialist
- good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity)
- consent to the study protocol
Key exclusion criteria (6 listed)
- diagnosed glaucoma
- diagnosed previous allergy
- diagnosed diabetic retinopathy or maculopathy
- previously diagnosed dry eye disease that requires treatment with multiple artificial tears
- permanent usage of the eye drops other than artificial tears
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 solution of standard post-cataract eye dropsUsage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%. | Other | preservatives-free dexamethasone 0.1% eye drops, preserved dexamethasone 0.1% eye drops |
Primary outcome
Best corrected visual acuity result
Time frame: up to 21 days post-surgery
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
Ocular staining score result
Time frame: up to 21 days post-surgery
standard staining score - a scale used with the fluorescein stain; higher value expres more severe outcome, normal values are around 0-1. Overal information can be found: https://entokey.com/a-simplified-quantitative-method-for-assessing-keratoconjunctivitis-sicca-from-the-sjogrens-syndrome-international-registry/
Ocular Surface Disease Index survey result
Time frame: up to 21 days post-surgery
a standard survey that patient will preform at each visit
5 secondary outcomes
Fluorescein Break-up Time assessment
Time frame: up to 21 days post-surgery
SICCA scale assessment
Time frame: up to 21 days post-surgery
Shirmer test 1 measurement
Time frame: up to 21 days post-surgery
Intraocular pressure measurement
Time frame: up to 21 days post-surgery
Anterior chamber cell intensity measurement
Time frame: up to 21 days post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 37903818Muzyka-Wozniak M, Strozecki L, Przezdziecka-Dolyk J. Assessment of the eye surface and subjective symptoms after using 0.1% dexamethasone drops with and without preservatives in patients after cataract surgery. Sci Rep. 2023 Oct 30;13(1):18625. doi: 10.1038/s41598-023-44939-1.
- Individual participant dataSharing planned: Undecided
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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.
Maria Muzyka-Woźniak, PhD principal investigator
Spektrum Clinic of Ophthalmology
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 solution of standard post-cataract eye drops in people with Cataract and Surgical Injury, run by Spektrum Center of Clinical Ophthalmology at 1 site in Poland.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Best corrected visual acuity result (time frame: up to 21 days post-surgery). The study lists 3 primary outcomes in all. 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 NCT05753787, 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 28 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.