180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

NCT02628223 | Completed Results DMC

• 1 other identifier: 21921
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

Conditions

Open Angle Glaucoma; Ocular Hypertension; Glaucoma, Open Angle, Pseudo-exfoliative; Pigment Dispersion Syndrome; Glaucoma

Keywords

glaucoma; Elevated IOP; Selective Laser Trabeculoplasty; SLT; open angle glaucoma; ocular hypertension; Glaucoma, Open Angle, Pseudo-exfoliative; pigment dispersion syndrome; Pseudoexfoliation; IOP ≥ 21 mmHg

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Three Months of Follow-up

  Intraocular pressure (IOP) measured by tonometry in millimeters of mercury at three months of follow-up

  3 months

Secondary Outcomes (3)

• Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at 1 Year of Follow-up

  1 year

• Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Time at Which Additional Glaucoma Therapy is Required

  within 1 year of study intervention

• Intraocular Pressure (IOP) Measured by Tonometry in Millimeters of Mercury at Last Follow-up

  within 1 year of study intervention

Other Outcomes (2)

• Number of Participants With Intraocular Pressure (IOP) Spike Assessed by Tonometry

  within 1 year of study intervention

• Number of Participants With Trabeculitis Assessed by Ophthalmic Exam and Gonioscopy

  within 1 year of study intervention

Study Arms (2)

180 degrees

ACTIVE COMPARATOR

180 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser

Procedure: Selective Laser Trabeculoplasty; Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser

360 degrees

ACTIVE COMPARATOR

360 degrees of Selective Laser Trabeculoplasty using Neodymium:Yttrium Aluminum Garnet (YAG) laser

Procedure: Selective Laser Trabeculoplasty; Device: Neodymium:Yttrium Aluminum Garnet (YAG) laser

Interventions

Selective Laser Trabeculoplasty PROCEDURE

The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Also known as: SLT

180 degrees; 360 degrees

Neodymium:Yttrium Aluminum Garnet (YAG) laser DEVICE

The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.

Also known as: Nd:YAG laser

180 degrees; 360 degrees

Eligibility Criteria

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

You may qualify if:

• patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
• greater than 18 years of age
• initial intraocular pressure (IOP) of ≥ 21 mmHg

You may not qualify if:

• prior medical or laser therapy to lower IOP
• previous incisional glaucoma surgery before the study period

Sponsors & Collaborators

• Temple University: lead

Study Sites (2)

Brandywine Eye Center

Wilmington, Delaware, 19810, United States

Location

Levin Luminais Chronister Eye Associates

Thorndale, Pennsylvania, 19372, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Glaucoma-Related Pigment Dispersion Syndrome

Interventions

Lasers

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

There were some limitations to this study that include: No standardized definition of who needed laser; No standardized technique other than the amount of meshwork lasered; No standardized IOP checking device; No standardized post op drop regimen; No standardized follow up interval.

Results Point of Contact

• Title: Dr. Jeffrey Henderer
• Organization: Temple University Hospital

Jeffrey.Henderer@tuhs.temple.edu

267-418-9126

Study Officials

• Jeffrey D. Henderer, MD

  Temple University

  PRINCIPAL INVESTIGATOR

• Sophia Siu, MD

  Temple University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 11, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 5, 2020
• Results First Posted: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)