CataractNCT02558218
Postoperative Discomfort and Ocular Redness Following Phacoemulsification Surgery
A study testing Systane Ultra and tobradex quid (Standard) 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 and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Cataract
- What is being tested?
- Systane Ultra and tobradex quid (Standard)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2015to May 2015
- 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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
- Endothelial cell count less than 1900,
- Glaucoma,
- IOP-lowering medications,
- Former incisional surgery,
- Former diagnosis of corneal disease,
- Diabetes or autoimmune diseases
- Former diagnosis of dry eye disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
Primary objective of the study is the assessment of the patients' discomfort and ocular redness 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) 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 Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).
- Conditions
- Cataract
- Being tested
- Systane Ultra, tobradex quid (Standard)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane UltraDrug
Also called Administration of Systane Ultra (Alcon)
Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months
tobradex quid (Standard)Drug
Also called Standard Medication
Standard medication (tobradex quid for 20 days)
| Study group | Role | What they receive |
|---|---|---|
| Systane ultra group | Active comparator | Participants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively. Receives: Drug: Systane Ultra |
| Control group | Active comparator | Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.] Receives: Drug: tobradex quid (Standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foreign body sensation
Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day
Measured: 1 month postoperatively
Secondary outcomes (2)
Ocular Redness
Ocular redness will be assessed by means of a validated photographic chart
Measured: 7 days postoperatively
Corneal Sensitivity
Corneal Sensitivity will be assessed by Cochet-Bonnet esthesiometer at the 7th and 30th postoperative day
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
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
- 80 participants (actual)
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, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558218
- Sponsor's protocol ID
- FBCat
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- 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 28497070
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Discomfort and Ocular Redness Following Phacoemulsification and Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT02558218
- Acronym / sponsor ID
- FBCat
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Sep 2015 (estimated)
- 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 and ocular redness 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) 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 Systane Ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane ultra group | Active comparator | Drug: Systane UltraParticipants in this group were administered systane ultra quid (Alcon, Fort Worth) for two months postoperatively), additionally to tobradex quid (Alcon, Fort Worth) for 20 days postoperatively. |
| Control group | Active comparator | Drug: tobradex quid (Standard)Participants in this group were administered the standard postoperative medication [tobradex quid (Alcon, Fort Worth) for 20 days postoperatively.] |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. 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)
- Endothelial cell count less than 1900,
- Glaucoma,
- IOP-lowering medications,
- Former incisional surgery,
- Former diagnosis of corneal disease,
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 |
|---|---|---|
| Systane UltraAlso: Administration of Systane Ultra (Alcon)Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months | Drug | Systane ultra group |
| tobradex quid (Standard)Also: Standard MedicationStandard medication (tobradex quid for 20 days) | Drug | Control group |
Primary outcome
Foreign body sensation
Time frame: 1 month postoperatively
Foreign body sensation will be assessed by a direct 5-scale, Likert type question that will be addressed to the participants at the 30th postoperative day
2 secondary outcomes
Ocular Redness
Time frame: 7 days postoperatively
Corneal Sensitivity
Time frame: 1 month postoperatively
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 23 Sep 2015.
- Derived from this study: 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.
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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 principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Ultra and tobradex quid (Standard) 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 23 Sep 2015. 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?
Foreign body sensation (time frame: 1 month postoperatively). 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 NCT02558218, 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 23 Sep 2015.