CataractDRY-CATNCT07581548
Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery
An observational study of Cataract and Dry Eye, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
The primary objective of this study is the assessment of three tear substitute formulations in terms of postoperative discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- What is being tested?
- Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max), Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) and Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- 1 May 2026to 1 May 2027
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent cataract extraction surgery
Who may be able to join
- Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale
Who cannot join
- Former incisional surgery
- Former diagnosis of corneal disease
- Autoimmune diseases
- Mental diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
Dimitrios Aggelonias, MSc, +30 2551030990, dangelon@affil.duth.gr
Eirini - Kanella Panagiotopoulou, panagiotopoulou.ek@gmail.com
About this study
Official title: Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery: A Non- Interventional, Observational Study
The primary objective of this study is the assessment of three tear substitute formulations in terms of postoperative discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.
Read the detailed description
Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA). All participants will be randomly assigned to three study groups. Study group 1 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate \& Dexpanthenol 2% (Hylopan max, Zwitter, Greece) quid for 12 weeks. Study group 2 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate \& Trehalose 3% (Thealoz duo, Thea, Greece) quid for 12 weeks. Study group 3 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.2% sodium hyaluronate and amino acids (Helenvision Ultra, Pharmex, Greece) quid for 12 weeks.
- Being tested
- Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max), Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo), Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)
- Keywords
- dry eye, cataract surgery, sodium hyaluronate, artificial tears
- Medical subject headings
- Cataract, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)Drug
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen
Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)Drug
Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen
Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)Drug
Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max) Receives: Drug: Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max) | |
| Study Group 2 | Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) Receives: Drug: Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) | |
| Study Group 3 | Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra) Receives: Drug: Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
A subjective parameter that quantifies corneal discomfort
Measured: 12 weeks
Tear Break-up Time (TBUT)
An objective parameter that quantifies stability of tear film
Measured: 12 weeks
Secondary outcomes (2)
Schirmer test (basal tear production)
An objective test that assesses basal tear production alone using topical anesthetic drops, by removing the stimulus that triggers reflex tearing.
Measured: 12 weeks
Efron scale for bulbar redness
A clinical tool consisting of five photographic, color-calibrated images (graded 0 to 4) that allow practitioners to classify the severity of conjunctival hyperaemia, ranging from normal to severe Grade 0: Normal, pale eyelid margin, minimal conjunctival vessels. Grade 1: Trace/Very Slight redness. Grade 2: Slight/Mild redness. Grade 3: Moderate redness. Grade 4: Severe redness.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, Prof, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581548
- Sponsor's protocol ID
- ES10/Th23/20-04-2026
- Acronym
- DRY-CAT
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017.
PubMed 28497070Ntonti P, Panagiotopoulou EK, Karastatiras G, Breyannis N, Tsironi S, Labiris G. Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2019 Feb 11;6:6. doi: 10.1186/s40662-019-0131-8. eCollection 2019.
PubMed 30805405
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Three Tear Substitute Formulations in Postoperative Discomfort After Cataract Surgery: A Non- Interventional, Observational Study
- ClinicalTrials.gov ID
- NCT07581548
- Acronym / sponsor ID
- DRY-CAT / ES10/Th23/20-04-2026
- Keywords
- dry eye, cataract surgery, sodium hyaluronate, artificial tears
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 May 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.
The primary objective of this study is the assessment of three tear substitute formulations in terms of postoperative discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.
Detailed description
Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA). All participants will be randomly assigned to three study groups. Study group 1 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate \& Dexpanthenol 2% (Hylopan max, Zwitter, Greece) quid for 12 weeks. Study group 2 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.15 % sodium hyaluronate \& Trehalose 3% (Thealoz duo, Thea, Greece) quid for 12 weeks. Study group 3 will receive a fixed combination of chloramphenicol and dexamethasone (Dexachlor, Cooper, Greece) quid for 4 weeks and 0.2% sodium hyaluronate and amino acids (Helenvision Ultra, Pharmex, Greece) quid for 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | – | Drug: Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max) |
| Study Group 2 | – | Drug: Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo) |
| Study Group 3 | – | Drug: Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cataract extraction surgery
Key inclusion criteria (1 listed)
- Diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale
Key exclusion criteria (4 listed)
- Former incisional surgery
- Former diagnosis of corneal disease
- Autoimmune diseases
- Mental diseases
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 |
|---|---|---|
| Sodium Hyaluronate 0.15% and Dexpanthenol 2% drops (Hylopan max)Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Dexpanthenol 2% quid in their postoperative regimen | Drug | Study Group 1 |
| Sodium Hyaluronate 0.15% and Trehalose 3% drops (Thealoz duo)Cataract patients will be administered Drops of Sodium Hyaluronate 0.15% and Trehalose 3% quid in their postoperative regimen | Drug | Study Group 2 |
| Sodium Hyaluronate 0.2% and Amino acids drops (Helenvision ultra)Cataract patients will be administered Drops of Sodium Hyaluronate 0.2% and Amino acids quid in their postoperative regimen | Drug | Study Group 3 |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: 12 weeks
A subjective parameter that quantifies corneal discomfort
Tear Break-up Time (TBUT)
Time frame: 12 weeks
An objective parameter that quantifies stability of tear film
2 secondary outcomes
Schirmer test (basal tear production)
Time frame: 12 weeks
Efron scale for bulbar redness
Time frame: 12 weeks
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 12 May 2026.
- Background: PubMed 28497070Labiris G, Ntonti P, Sideroudi H, Kozobolis V. Impact of polyethylene glycol 400/propylene glycol/hydroxypropyl-guar and 0.1% sodium hyaluronate on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2017 May 10;4:13. doi: 10.1186/s40662-017-0079-5. eCollection 2017.
- Background: PubMed 30805405Ntonti P, Panagiotopoulou EK, Karastatiras G, Breyannis N, Tsironi S, Labiris G. Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis (Lond). 2019 Feb 11;6:6. doi: 10.1186/s40662-019-0131-8. eCollection 2019.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Georgios Labiris, MD, Prof study chair
Democritus University of Thrace
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 Cataract and Dry Eye, run by Democritus University of Thrace at 1 site in Greece.
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 1 inclusion and 4 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 12 May 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 Greece. 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 Eirini - Kanella Panagiotopoulou, MD, MSc, PhD (+30 6978730858, panagiotopoulou.ek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT07581548, which also lists 2 linked publications.
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 12 May 2026.