Glaucoma, Closed-AngleNCT02955641
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
A study testing Dexamethasone Disodium Phosphate 0.1%, Nepafenac 0.1% and Hydroxyethylcellulose 0.19% in people with Glaucoma, Closed-Angle and Glaucoma, Narrow-Angle, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma, Closed-Angle, Glaucoma, Narrow-Angle, Glaucoma, Angle-Closure
- What is being tested?
- Dexamethasone Disodium Phosphate 0.1%, Nepafenac 0.1% and Hydroxyethylcellulose 0.19%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2016to Nov 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary narrow/closed angle by gonioscopy
- Able to give consent
- Ability to attend follow-up visits
Who cannot join
- Corneal disease preventing sufficient evaluation of the angle
- Secondary closed angle (e.g. uveitis related)
- Pregnant women
- Previous eye surgery other than laser refractive correction
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer
Ari Leshno, arileshno@gmail.com
About this study
The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.
Read the detailed description
Primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. Laser peripheral iridotomy (LPI) is a common and simple treatment used for both treatment and prevention of acute angle closure event.
Anti-inflammatory drops are commonly prescribed to patients undergoing LPI in order to prevent or reduce post-treatment discomfort. However, to date, there are no specific guidelines for post LPI anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment.
In the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) on post LPI symptoms and inflammation markers.
- Being tested
- Dexamethasone Disodium Phosphate 0.1%, Nepafenac 0.1%, Hydroxyethylcellulose 0.19%
- Keywords
- Laser peripheral iridotomy, topical anti-inflammatory drops
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Disodium Phosphate 0.1%Drug
Also called Sterodex
four drops a day for four days after LPI treatment
Nepafenac 0.1%Drug
Also called Nevanac
four drops a day for four days after LPI treatment
Hydroxyethylcellulose 0.19%Drug
Also called Lyteers ophthalmic solution
four drops a day for four days after LPI treatment
| Study group | Role | What they receive |
|---|---|---|
| NSAIDs-Placebo | Active comparator | Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye Receives: Drug: Nepafenac 0.1%; Drug: Hydroxyethylcellulose 0.19% |
| Placebo-NSAIDs | Active comparator | Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye Receives: Drug: Nepafenac 0.1%; Drug: Hydroxyethylcellulose 0.19% |
| Steroid-Placebo | Active comparator | Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye Receives: Drug: Dexamethasone Disodium Phosphate 0.1%; Drug: Hydroxyethylcellulose 0.19% |
| Placebo-Steroids | Active comparator | Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye Receives: Drug: Dexamethasone Disodium Phosphate 0.1%; Drug: Hydroxyethylcellulose 0.19% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Using VAS pain scale
Measured: At four days post LPI treatment
Symptoms score
Using a modified questionnaire based on the ocular surface disease index.
Measured: At four days post LPI treatment
Secondary outcomes (3)
Grading of cells in the anterior chamber
Assessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber cells
Measured: At four days post LPI treatment
Patency of LPI by visualisation
Assessed on slit-lamp examination using transilumination and visualising the site of LPI treatment for the presence (patent) or obsence (closed) of transilumination defect
Measured: up to 30 days post LPI treatment
Grading of flare in anterior chamber
Assessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber flare
Measured: At four days post LPI treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 Nov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Closed-AngleStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ari Leshno, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955641
- Sponsor's protocol ID
- SHEBA-16-3197-AL-CTIL
- Status last verified
- Apr 2018
- First submitted
- 5 Sep 2016
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
- ClinicalTrials.gov ID
- NCT02955641
- Acronym / sponsor ID
- SHEBA-16-3197-AL-CTIL
- Keywords
- Laser peripheral iridotomy, topical anti-inflammatory drops
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 4 Nov 2016 (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.
The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.
Detailed description
Primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. Laser peripheral iridotomy (LPI) is a common and simple treatment used for both treatment and prevention of acute angle closure event.
Anti-inflammatory drops are commonly prescribed to patients undergoing LPI in order to prevent or reduce post-treatment discomfort. However, to date, there are no specific guidelines for post LPI anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment.
In the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) on post LPI symptoms and inflammation markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NSAIDs-Placebo | Active comparator | Drug: Nepafenac 0.1%, Drug: Hydroxyethylcellulose 0.19%Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye |
| Placebo-NSAIDs | Active comparator | Drug: Nepafenac 0.1%, Drug: Hydroxyethylcellulose 0.19%Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye |
| Steroid-Placebo | Active comparator | Drug: Dexamethasone Disodium Phosphate 0.1%, Drug: Hydroxyethylcellulose 0.19%Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye |
| Placebo-Steroids | Active comparator | Drug: Dexamethasone Disodium Phosphate 0.1%, Drug: Hydroxyethylcellulose 0.19%Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary narrow/closed angle by gonioscopy
- Able to give consent
- Ability to attend follow-up visits
Key exclusion criteria (4 listed)
- Corneal disease preventing sufficient evaluation of the angle
- Secondary closed angle (e.g. uveitis related)
- Pregnant women
- Previous eye surgery other than laser refractive correction
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 |
|---|---|---|
| Dexamethasone Disodium Phosphate 0.1%Also: Sterodexfour drops a day for four days after LPI treatment | Drug | Placebo-Steroids, Steroid-Placebo |
| Nepafenac 0.1%Also: Nevanacfour drops a day for four days after LPI treatment | Drug | NSAIDs-Placebo, Placebo-NSAIDs |
| Hydroxyethylcellulose 0.19%Also: Lyteers ophthalmic solutionfour drops a day for four days after LPI treatment | Drug | NSAIDs-Placebo, Placebo-NSAIDs, Placebo-Steroids, Steroid-Placebo |
Primary outcome
Pain score
Time frame: At four days post LPI treatment
Using VAS pain scale
Symptoms score
Time frame: At four days post LPI treatment
Using a modified questionnaire based on the ocular surface disease index.
3 secondary outcomes
Grading of cells in the anterior chamber
Time frame: At four days post LPI treatment
Patency of LPI by visualisation
Time frame: up to 30 days post LPI treatment
Grading of flare in anterior chamber
Time frame: At four days post LPI treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- 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.
Ari Leshno, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Disodium Phosphate 0.1%, Nepafenac 0.1% and Hydroxyethylcellulose 0.19% in people with Glaucoma, Closed-Angle and Glaucoma, Narrow-Angle, run by Sheba Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 24 Apr 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ari Leshno, MD (+972-3-5302874, ari.leshano@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: At four days post LPI treatment). 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?
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 24 Apr 2018.