The Laser in Pseudoexfoliation (LIP) Study

NCT01704989 | Withdrawn Phase 4

• 1 other identifier: LIP-SLT-2012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Glaucoma

Keywords

Glaucoma, SLT

Outcome Measures

Primary Outcomes (2)

• Number of drops (and surgical interventions) needed to reach target IOP.

  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.

  At 6 months, 12 months and 2 years

Secondary Outcomes (3)

• Correlation of angle pigment grade with IOP reduction from SLT

  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

  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.

  2 years

Study Arms (2)

Laser pathway

ACTIVE COMPARATOR

Arm in which patients first randomised to receive SLT laser

Procedure: SLT Laser

Topical therapy

ACTIVE COMPARATOR

Arm in which patients first selected to receive drops (Prostagladin analogue as first-line)

Drug: Prostagladin

Interventions

SLT Laser PROCEDURE

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.

Also known as: Slective Laser Trabeculoplasty (primary treatment)

Laser pathway

Prostagladin DRUG

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.

Also known as: B-Blocker, Carbonic anydrase inhibitor

Topical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

Study Sites (1)

Eye Care Centre, VG Site, QEII

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Related Publications (1)

• 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.

  PMID: 35943114 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Marcelo T Nicoela, MD

  Capital District Health Authority/Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: October 12, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 21, 2024

Record last verified: 2012-10

Locations

CA (1)