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Completed

NCT Number: NCT02995629

Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation

Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to achieve gray-white retinal burns and duration of treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

As demonstrated in the Diabetic Retinopathy Study (DRS), panretinal photocoagulation (PRP) reduces the risk of severe vision loss in patients with proliferative diabetic retinopathy. The DRS recommended that PRP treatment consist of 1,200 - 1,600 laser burns 500 µm in size, one half to one burn width apart, applied to the peripheral retina in a scatter fashion. Most patients who undergo PRP experience discomfort/pain during the procedure. Once present, pain can affect the number and quality of burns delivered and can indirectly increase the number of sessions required to complete the therapy.This may in turn adversely affect patient compliance. Although retrobulbar and peribulbar blocks can provide adequate anesthesia for PRP, these anesthetic methods carry rare but serious risks such as retrobulbar hemorrhage. Previous studies have explored other ways to reduce discomfort related to PRP, including optimization of laser settings, oral and topical analgesics, subconjunctival anesthesia, and even acupuncture.

Currently, green lasers (521 - 532 nm wavelength) are most commonly utilized for performing PRP in clinical practice. Yellow lasers (577 nm wavelength) have been of recent interest in treating diabetic macular edema with micropulse subthreshold grid photocoagulation, but have not been extensively studied in PRP for diabetic retinopathy. Compared to shorter wavelength laser, yellow laser comports high transmission through dense ocular media and less light scattering than shorter wavelengths which minimizes spot size and reduces thermal spread. The limited literature comparing green and yellow laser for PRP in diabetic retinopathy has shown that yellow laser requires less power to achieve a retinal burn. In theory this should translate into a reduction in perceived pain experienced during PRP, however a comparison of green and yellow lasers in this regard has not yet been directly examined and quantified.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina
  • volunteer patients age 18 years and older.
  • healthy enough to participate in the study.
  • willing and able to consent to participation in the study.
  • diagnosis of PDR with HRC based on clinical criteria outlined by the DRS.

Exclusion criteria

  • patient less than 18 years of age
  • institutionalized patient
  • prisoner
  • significant media opacity obscuring a view of the superior retina
  • history of intra-ocular surgery except cataract surgery
  • history of PRP laser within the last 30 days

Treatment and study plan

laser indirect ophthalmoscopy pan retinal photocoagulation

Procedure
  • Prior to procedure, eligible patient is dilated and a topical anesthesia is administered 3 to 5 minutes prior to treatment initiation
  • Treatment duration is fixed at 50 minutes and power is titrated until moderate gray-white burns are achieved, avoiding long ciliary nerves
  • Target treatment of 250 spots
  • Only one eye per eligible patient randomized with regard to whether green or yellow laser utilized first
  • After treatment,pain assessment conducted:spot count, laser parameters and treatment duration recorded for each respective laser wavelength

Other names: PRP laser

Primary outcomes

  1. Perceived patient pain assessment

    Time frame: a single time point within 2 minutes of completing laser treatment

    Assessed using a standardized Wong-Baker faces pain scale

Secondary outcomes

  1. Minimum power requirement to achieve moderate gray-white retinal burns

    Time frame: During treatment

  2. Time of treatment

    Time frame: During treatment

    Time required to treat with each laser

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Mid Atlantic Retina

Registry information

Official study title

Patient Comfort Using Green (532 nm) Versus Yellow (577 nm) Laser Indirect Ophthalmoscopy Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2016
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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