The Laser in Pseudoexfoliation (LIP) Study (LIP)
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|ClinicalTrials.gov Identifier: NCT01704989|
Recruitment Status : Unknown
Verified October 2012 by Marcelo Nicolela, Nova Scotia Health Authority.
Recruitment status was: Not yet recruiting
First Posted : October 12, 2012
Last Update Posted : October 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Procedure: SLT Laser Drug: Prostagladin||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Laser pathway
Arm in which patients first randomised to receive SLT laser
Procedure: SLT Laser
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.
Other Name: Slective Laser Trabeculoplasty (primary treatment)
Active Comparator: Topical therapy
Arm in which patients first selected to receive drops (Prostagladin analogue as first-line)
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704989
|Contact: Marcelo T Nicolela, MDfirstname.lastname@example.org|
|Canada, Nova Scotia|
|Eye Care Centre, VG Site, QEII|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Contact: Marcelo T Nicolela, MD 902-473-3622 email@example.com|
|Principal Investigator: Marcelo T Nicolela, MD|
|Sub-Investigator: Lesya Shuba, MD|
|Sub-Investigator: Rizwan Malik, MD|
|Sub-Investigator: Paul Rafuse, MD|
|Sub-Investigator: Balwantray Chauhan, PhD|
|Principal Investigator:||Marcelo T Nicoela, MD||Capital District Health Authority/Dalhousie University|