CataractNCT03705949
Impact of 0.1% and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Phacoemulsification Surgery
A study testing Sodium Hyaluronate 0.1% drops and Sodium Hyaluronate 0.2% drops in people with Cataract, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of the study is the assessment of the patients' discomfort following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Sodium Hyaluronate 0.1% drops and Sodium Hyaluronate 0.2% drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- 15 Sep 2017to 15 Sep 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- Diagnosis or evidence of dry-eye-disease (DED)
- IOP-lowering medications
- Former incisional surgery
- Former diagnosis of corneal disease
- Diabetes
- Autoimmune diseases
- Mental diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Impact of 0.1% Sodium Hyaluronate and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Cataract Extraction Surgery, a Comparative Study
Primary objective of the study is the assessment of the patients' 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), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group [who will receive fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks], and control group [who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks].
- Conditions
- Cataract
- Being tested
- Sodium Hyaluronate 0.1% drops, Sodium Hyaluronate 0.2% drops
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hyaluronate 0.1% dropsDrug
Also called Sodium Hyaluronate 0.1% drops (artificial tear medication)
Patients will be administered Drops of Sodium Hyaluronate 0.1% quid
Sodium Hyaluronate 0.2% dropsDrug
Also called Sodium Hyaluronate 0.2% drops (artificial tear medication)
Patients will be administered Drops of Sodium Hyaluronate 0.2% quid
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Sodium Hyaluronate 0.1% drops Receives: Drug: Sodium Hyaluronate 0.2% drops |
| Control group | Active comparator | Sodium Hyaluronate 0.2% drops Receives: Drug: Sodium Hyaluronate 0.1% drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Discomfort Index
A subjective parameter that quantifies corneal discomfort
Measured: 6 weeks
Secondary outcomes (2)
Break up time
An objective parameter that quantifies stability of tear film
Measured: 6 weeks
Central Corneal Sensitivity
An objective parameter that quantifies corneal sensitivity
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start15 Sep 2017
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Hospital, Athens, George Papanicolaou Hospital, Athinaiki General Clinic
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD, PhD, Study director, University Hospital of Alexandroupolis, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705949
- Sponsor's protocol ID
- 226/15-03-2018
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ntonti 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 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 0.1% Sodium Hyaluronate and 0.2% Sodium Hyaluronate on Postoperative Discomfort Following Cataract Extraction Surgery, a Comparative Study
- ClinicalTrials.gov ID
- NCT03705949
- Acronym / sponsor ID
- 226/15-03-2018
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Collaborators
- Naval Hospital, Athens, George Papanicolaou Hospital, Athinaiki General Clinic
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 15 Oct 2018 (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.
Primary objective of the study is the assessment of the patients' 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), the Naval Hospital in Athens, the Papanikolaou General Hospital in Thessaloniki, and Athinaiki General Clinic in Athens in a consecutive-if-eligible basis. By means of a custom computer randomization program all participants will randomly populate either study group [who will receive fixed combination of tobramycin and dexamethasone (FCTD), (Tobradex, Alcon, Greece) quid for 3 weeks and 0.2 % sodium hyaluronate (Hylogel, Pharmex, Greece) quid for 6 weeks], and control group [who will receive Tobradex quid for 3 weeks and 0.1 % sodium hyaluronate (Hylocomod) quid for 6 weeks].
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Drug: Sodium Hyaluronate 0.2% dropsSodium Hyaluronate 0.1% drops |
| Control group | Active comparator | Drug: Sodium Hyaluronate 0.1% dropsSodium Hyaluronate 0.2% drops |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 (7 listed)
- Diagnosis or evidence of dry-eye-disease (DED)
- IOP-lowering medications
- Former incisional surgery
- Former diagnosis of corneal disease
- Diabetes
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 0.1% dropsAlso: Sodium Hyaluronate 0.1% drops (artificial tear medication)Patients will be administered Drops of Sodium Hyaluronate 0.1% quid | Drug | Control group |
| Sodium Hyaluronate 0.2% dropsAlso: Sodium Hyaluronate 0.2% drops (artificial tear medication)Patients will be administered Drops of Sodium Hyaluronate 0.2% quid | Drug | Study group |
Primary outcome
Surface Discomfort Index
Time frame: 6 weeks
A subjective parameter that quantifies corneal discomfort
2 secondary outcomes
Break up time
Time frame: 6 weeks
Central Corneal Sensitivity
Time frame: 6 weeks
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 15 Oct 2018.
- Derived from this study: 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.
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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.
Georgios Labiris, MD, PhD study director
University Hospital of Alexandroupolis, 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?
A study testing Sodium Hyaluronate 0.1% drops and Sodium Hyaluronate 0.2% drops in people with Cataract, 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 7 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 15 Oct 2018. 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?
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?
Surface Discomfort Index (time frame: 6 weeks). 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 NCT03705949, 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 15 Oct 2018.