How Safe and Effective is Micropulse Transscleral Cyclophotocoagulation in Patients With Uncontrolled Glaucoma?
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the surgical outcomes of the micropulse
      transscleral cyclophotocoagulation (mTSCPC) in patients with uncontrolled glaucoma; analyze
      intraocular pressure lowering effect; and correlate related treatment parameters pending
      enrollment of sufficient numbers of dark pigmented versus light pigmented eyes.
    

Detailed description: 
      If the subject agrees to participate in this study, he/she will come in for a screening visit
      to make sure they qualify for the study. Following the surgical procedure, principal
      investigator will perform a standard postoperative examination at Day 1, Week 1, Month

      1, Month 3, Month 6 and Month 12, in addition to any other visits the investigator feels may
      be necessary.

      Screening Visit: At the screening visit, the subjects medical history and current medications
      will be reviewed. Pre-operative eye pressure and visual acuity will be noted. The Kowa Flare
      Meter-500 laser flare meter and slit lamp (the table-top microscope used for examining the
      eye) will be used to measure inflammation in subjects anterior chamber (the fluid-filled
      space between the iris (colored part of the eye) and cornea (clear front part of the eye that
      covers the iris and pupil).

      Surgery: On the day of the subjects surgery, the subject will undergo the standard procedure
      for transscleral cyclophotocoagulation (TSCPC) laser surgery using the micropulse delivery
      mode of diode laser. After the Principal investigator finishes with the laser, he/she will
      perform anterior chamber paracentesis, which will help reduce the pressure in the subjects
      eye quickly and temporarily. To do this, the principal investigator will puncture the cornea
      (the clear front part of the eye that transmits and focuses light into the eye) to remove
      some of the aqueous (fluid inside the eye). Paracentesis is usually not done if TSCPC is
      performed using the "continuous" delivery mode.

      Post-Operative Exams: At each of the post-operative office visits (Day 1, Week 1, Months 1,
      3, 6 and 12) a detailed medical/eye history will be taken, including all current medications,
      vision will be tested and an eye examination will be performed, including measurement of eye
      pressure. Subject will be asked about his/her comfort level in regards to pain. At visit Day
      1 and Month 1 the amount of anterior chamber inflammation will again be measured (as
      described in Screening Visit).
    

Intervention name(s): Micropulse Transscleral Cyclophotocoagulation
Intervention type(s): Procedure
Intervention description(s): In mTSCPC, a diode laser is used to damage tissue of the ciliary body, the tissue inside the eye that produces aqueous, the clear fluid in the eye that maintains intraocular pressure. This causes it to produce less aqueous.
Other intervention name(s): mTSCPC
Intervention model: Single Group Assignment
Intervention model description: Diode Laser Cyclophotocoagulation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma; Micropulse Transscleral Cyclophotocoagulation; Intraocular Pressure