GlaucomaPhase 4LIPNCT01704989
The Laser in Pseudoexfoliation (LIP) Study
A Phase 4 study testing SLT Laser and Prostagladin in people with Glaucoma, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this region an ideal setting for studying patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- SLT Laser and Prostagladin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of PXF material on the anterior chamber structures by slit lamp biomicroscopy.
- An open drainage angle with no irido-trabecular contact on non-indentation gonioscopy in primary position trabecular meshwork visible over 360 degrees.
- Ocular hypertension or glaucoma deemed to require treatment by the attending clinician.
- A decision to treat has been made by a Consultant Glaucoma Specialist.
- Age over 18 years and able to provide informed consent.
Who cannot join
- Advanced glaucoma as determined by EMGT criteria 1: visual field loss mean deviation worse than -12 dB in the better or -15 dB in the worse eye.
- Co-existing other secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis etc) or angle closure glaucoma.
- History of retinal ischaemia, macular oedema or diabetic retinopathy.
- Age-related macular degeneration with neovascularisation or geographic atrophy and VA worse than 6/36.
- Any previous intra-ocular surgery, except uncomplicated phacoemulsification at least one year before.* Medically unfit for completion of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Compare the Clinical Effectiveness of Selective Laser Trabeculoplasty (SLT) Versus Topical Therapy in the Treatment of Pseudoexfoliative Glaucoma
A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this region an ideal setting for studying patients with this condition. Despite associated high morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for the clinician. Topical medical therapy is less effective than for primary open angle glaucoma and patients often require early surgical therapy, with associated risks. Selective laser trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma, although the evidence for this is presently lacking. The aim of the current study is to provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical therapy, in the management of pseudoexfoliative glaucoma.
Read the detailed description
Objectives:
The primary aim of this study is to compare the effectiveness, in terms of intraocular pressure (IOP) control, of SLT and topical medical therapy in the primary treatment of patients with high IOP secondary to PXF. The secondary aims of the study are:
- To examine the relationship between the degree of angle pigmentation and reduction of IOP
- To examine adverse effects from SLT treatment in patients with PXF
- To compare IOP-lowering effects of SLT in patients with PXF to patients with POAG (in the LiGHT study, see structure below).
Study Population: All new patients with PXF who are naïve to treatment (and willing to participate) will be recruited after their first hospital consultation. Both eyes will be treated but only one eye per patient included in the analysis (eye with the higher presenting IOP).
Structure: The study design mirrors that of National Institute of Health (NIHR-) funded, the laser in glaucoma and ocular hypertension trial (LiGHT) in the UK and is a collaborative study between a Canadian Institute and Moorfields Eye Hospital in London. This is a single-study randomised (unmasked) control trial of a proposed treatment intervention (SLT) versus a standard treatment (topical therapy).
Summary of study design Patients will be randomised to one of 2 trial arms: 'laser-pathway' or 'medicine- pathway'. Following initial treatment, SLT patients will be followed up 1-2 weeks after treatment to check IOP and for potential side effects. The interval of subsequent follow-up visits (between 4 and 12 months) will be governed by the level of IOP in relation to the target IOP and the severity of glaucoma. Visual field testing (SITA standard, 24-2 test pattern) and imaging with the Hedidelberg Retina Tomograph (HRT III) will be performed at each visit. Target IOP will be set using the Canadian Glaucoma Society guidelines depending on the severity of glaucoma and the level of IOP. At subsequent visits, treatment will be escalated if the target IOP is not met or if there is evidence of progression.
Duration of study The study will last 3 years. One year will be allowed for recruitment of all study participants, so that a minimum follow-up of 2 years will be available.
All patients will have a medical history, gonioscopy, central corneal thickness (CCT) measurement, IOP measurement with Goldmann applanation tonometry and dilated fundoscopy at the baseline visit.
- Conditions
- Glaucoma
- Being tested
- SLT Laser, Prostagladin
- Keywords
- Glaucoma, SLT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLT LaserProcedure or surgery
Also called Slective Laser Trabeculoplasty (primary treatment)
At the first treatment, SLT treatment will be delivered to 360 degrees of trabecular meshwork. At the first escalation of treatment, the superior 180 degrees will be retreated. Twenty-five non-overlapping shots per quadrant will be used with a starting power of 0.8 mJ and increments of 0.1 mJ (titrated to avoid large bubbles) with standard other settings (400 nm spot size, 3 nanosecond duration) using a Latina single-mirror goniolens. The IOP will be checked 1 hour post treatment and five days of guttae acular tds will be administered to the treatment eye following treatment. After 2 treatments of SLT, the laser treated arm of the study will follow the same pathway as the medical treatment arm.
ProstagladinDrug
Also called B-Blocker, Carbonic anydrase inhibitor
Treatment will be initiated with latanoprost 0.005%. At the first IOP check (1-2 months), if the IOP has not reached target IOP, a second line agent will be added (β-Blocker unless contraindicated). If target IOP is still not reached, a third agent will be considered (topical carbonic anhydrase inhibitor). Treatment may be switched, instead, at the discretion of the clinician if the reduction of IOP with an agent is deemed to be no different than the pre-treatment IOP. Surgical therapy will be considered if target IOP is not met, or there is high IOP (>35 mmHg) or advanced damage at presentation.
| Study group | Role | What they receive |
|---|---|---|
| Laser pathway | Active comparator | Arm in which patients first randomised to receive SLT laser Receives: Procedure: SLT Laser |
| Topical therapy | Active comparator | Arm in which patients first selected to receive drops (Prostagladin analogue as first-line) Receives: Drug: Prostagladin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drops (and surgical interventions) needed to reach target IOP.
Measured: Change in IOP at 6 months, 12 months and 2 years (from baseline).
Percentage success
Proportion of patients in whom SLT (or mono medical therapy) alone achieved target IOP.
Measured: At 6 months, 12 months and 2 years
Secondary outcomes (3)
Correlation of angle pigment grade with IOP reduction from SLT
Measured: 6 months, 12 months, 2 years
Comparison of percentage success and number of drops in current study with the equivalent results of patients with POAG in the LiGHT study
Measured: 1 year and 2 years
Number of progressing patients in each study arm (SLT or medical therapy) in terms of visual field loss and HRT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Did not submit to the REB
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 GlaucomaStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Marcelo T Nicoela, MD, Principal investigator, Capital District Health Authority/Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704989
- Sponsor's protocol ID
- LIP-SLT-2012
- Acronym
- LIP
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2012
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PubMed 35943114
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare the Clinical Effectiveness of Selective Laser Trabeculoplasty (SLT) Versus Topical Therapy in the Treatment of Pseudoexfoliative Glaucoma
- ClinicalTrials.gov ID
- NCT01704989
- Acronym / sponsor ID
- LIP / LIP-SLT-2012
- Conditions
- Glaucoma
- Keywords
- Glaucoma, SLT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not submit to the REB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Oct 2012 (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.
A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this region an ideal setting for studying patients with this condition. Despite associated high morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for the clinician. Topical medical therapy is less effective than for primary open angle glaucoma and patients often require early surgical therapy, with associated risks. Selective laser trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma, although the evidence for this is presently lacking. The aim of the current study is to provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical therapy, in the management of pseudoexfoliative glaucoma.
Detailed description
Objectives:
The primary aim of this study is to compare the effectiveness, in terms of intraocular pressure (IOP) control, of SLT and topical medical therapy in the primary treatment of patients with high IOP secondary to PXF. The secondary aims of the study are:
- To examine the relationship between the degree of angle pigmentation and reduction of IOP
- To examine adverse effects from SLT treatment in patients with PXF
- To compare IOP-lowering effects of SLT in patients with PXF to patients with POAG (in the LiGHT study, see structure below).
Study Population: All new patients with PXF who are naïve to treatment (and willing to participate) will be recruited after their first hospital consultation. Both eyes will be treated but only one eye per patient included in the analysis (eye with the higher presenting IOP).
Structure: The study design mirrors that of National Institute of Health (NIHR-) funded, the laser in glaucoma and ocular hypertension trial (LiGHT) in the UK and is a collaborative study between a Canadian Institute and Moorfields Eye Hospital in London. This is a single-study randomised (unmasked) control trial of a proposed treatment intervention (SLT) versus a standard treatment (topical therapy).
Summary of study design Patients will be randomised to one of 2 trial arms: 'laser-pathway' or 'medicine- pathway'. Following initial treatment, SLT patients will be followed up 1-2 weeks after treatment to check IOP and for potential side effects. The interval of subsequent follow-up visits (between 4 and 12 months) will be governed by the level of IOP in relation to the target IOP and the severity of glaucoma. Visual field testing (SITA standard, 24-2 test pattern) and imaging with the Hedidelberg Retina Tomograph (HRT III) will be performed at each visit. Target IOP will be set using the Canadian Glaucoma Society guidelines depending on the severity of glaucoma and the level of IOP. At subsequent visits, treatment will be escalated if the target IOP is not met or if there is evidence of progression.
Duration of study The study will last 3 years. One year will be allowed for recruitment of all study participants, so that a minimum follow-up of 2 years will be available.
All patients will have a medical history, gonioscopy, central corneal thickness (CCT) measurement, IOP measurement with Goldmann applanation tonometry and dilated fundoscopy at the baseline visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser pathway | Active comparator | Procedure: SLT LaserArm in which patients first randomised to receive SLT laser |
| Topical therapy | Active comparator | Drug: ProstagladinArm in which patients first selected to receive drops (Prostagladin analogue as first-line) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Evidence of PXF material on the anterior chamber structures by slit lamp biomicroscopy.
- An open drainage angle with no irido-trabecular contact on non-indentation gonioscopy in primary position trabecular meshwork visible over 360 degrees.
- Ocular hypertension or glaucoma deemed to require treatment by the attending clinician.
- A decision to treat has been made by a Consultant Glaucoma Specialist.
- Age over 18 years and able to provide informed consent.
Key exclusion criteria (5 listed)
- Advanced glaucoma as determined by EMGT criteria 1: visual field loss mean deviation worse than -12 dB in the better or -15 dB in the worse eye.
- Co-existing other secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis etc) or angle closure glaucoma.
- History of retinal ischaemia, macular oedema or diabetic retinopathy.
- Age-related macular degeneration with neovascularisation or geographic atrophy and VA worse than 6/36.
- Any previous intra-ocular surgery, except uncomplicated phacoemulsification at least one year before.* Medically unfit for completion of the trial.
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 |
|---|---|---|
| SLT LaserAlso: Slective Laser Trabeculoplasty (primary treatment)At the first treatment, SLT treatment will be delivered to 360 degrees of trabecular meshwork. At the first escalation of treatment, the superior 180 degrees will be retreated. Twenty-five non-overlapping shots per quadrant will be used with a starting power of 0.8 mJ and increments of 0.1 mJ (titrated to avoid large bubbles) with standard other settings (400 nm spot size, 3 nanosecond duration) using a Latina single-mirror goniolens. The IOP will be checked 1 hour post treatment and five days of guttae acular tds will be administered to the treatment eye following treatment. After 2 treatments of SLT, the laser treated arm of the study will follow the same pathway as the medical treatment arm. | Procedure or surgery | Laser pathway |
| ProstagladinAlso: B-Blocker, Carbonic anydrase inhibitorTreatment will be initiated with latanoprost 0.005%. At the first IOP check (1-2 months), if the IOP has not reached target IOP, a second line agent will be added (β-Blocker unless contraindicated). If target IOP is still not reached, a third agent will be considered (topical carbonic anhydrase inhibitor). Treatment may be switched, instead, at the discretion of the clinician if the reduction of IOP with an agent is deemed to be no different than the pre-treatment IOP. Surgical therapy will be considered if target IOP is not met, or there is high IOP (>35 mmHg) or advanced damage at presentation. | Drug | Topical therapy |
Primary outcome
Number of drops (and surgical interventions) needed to reach target IOP.
Time frame: Change in IOP at 6 months, 12 months and 2 years (from baseline).
Percentage success
Time frame: At 6 months, 12 months and 2 years
Proportion of patients in whom SLT (or mono medical therapy) alone achieved target IOP.
3 secondary outcomes
Correlation of angle pigment grade with IOP reduction from SLT
Time frame: 6 months, 12 months, 2 years
Comparison of percentage success and number of drops in current study with the equivalent results of patients with POAG in the LiGHT study
Time frame: 1 year and 2 years
Number of progressing patients in each study arm (SLT or medical therapy) in terms of visual field loss and HRT.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 35943114Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
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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.
Marcelo T Nicoela, MD principal investigator
Capital District Health Authority/Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SLT Laser and Prostagladin in people with Glaucoma, run by Nova Scotia Health Authority at 1 site in Canada.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of drops (and surgical interventions) needed to reach target IOP. (time frame: Change in IOP at 6 months, 12 months and 2 years (from baseline).). 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 NCT01704989, 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 21 Aug 2024.