An interventional study of preservative-free solution of standard post-cataract eye drops in Cataract, Surgical Injury and Healing Wound, sponsored by Spektrum Center of Clinical Ophthalmology. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Spektrum Center of Clinical Ophthalmology · Not applicable, Interventional, and Health services research
Among 14 studies in Cataract with a site in Poland — 4 open to participants now, 5 under way, none of them phase 3. Cataract · Poland.
Among the 14 studies in Cataract with a site in Poland, this one is the 7th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2022, is one of 8 with no phase, and was the 9th registered.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →4 of the 14 studies in Cataract with a site in Poland are open now. Recruiting first, the newest first:
Pomeranian Medical University Szczecin · Sites in Poland
Military Institute od Medicine National Research Institute · Sites in Poland
Medical University of Bialystok · Sites in Poland
Sensor Cliniq · Sites in Poland
A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →
Of the 141 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2022.
This study's planned enrollment of 40 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Median enrollment 84 across the 10 interventional studies, 132 across the 4 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.
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3 of 14 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Spektrum Center of Clinical Ophthalmology as lead sponsor.
Spektrum Center of Clinical Ophthalmology has 1 study filed under Cataract — fewer than ten, so there is no comparison to draw.
2 of the studies in Cataract with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07462000Military Institute od Medicine National Research InstituteAqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract | 2027-01-21 |
| NCT06891092Medical University of BialystokVivinex Impress XY1-EM vs RayOne EMV | 2027-06-01 |
Among the 14 studies in Cataract with a site in Poland, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: preservative-free solution of standard post-cataract eye drops
Other: preservative-free solution of standard post-cataract eye drops
Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.
Best corrected visual acuity result
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
Time frame: 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/
Time frame: up to 21 days post-surgery
Ocular Surface Disease Index survey result
a standard survey that patient will preform at each visit
Time frame: up to 21 days post-surgery
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)
Time frame: 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
Time frame: 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
Time frame: up to 21 days post-surgery
Intraocular pressure measurement
Intraocular pressure measurement preformed by standard tonometer
Time frame: 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
Time frame: up to 21 days post-surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2023, 23 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 23 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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