Glaucoma Trial, Recruiting NCT07428668 Sponsor: Ophthalmology Associates, Fort Worth Condition: Glaucoma
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Glaucoma Trial, Recruiting

NCT07428668
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older, of any gender.
  • People who are able and willing to attend follow-up eye appointments for 6 months after the procedure.
  • People who are willing to sign a consent form approved by the relevant ethics review board.
  • People who have been diagnosed with open-angle glaucoma (including primary, pseudoexfoliation, or pigmentary types) of any severity, or ocular hypertension (higher-than-normal eye pressure without glaucoma damage), in the eye being treated.
  • People currently using zero to three types of eye drop medications to lower eye pressure (note: combination eye drops that contain two medications in one bottle count as two medications).
  • People whose eye anatomy, as assessed by a special angle examination called gonioscopy, shows the drainage area of the eye is clearly visible, appears normal, and has no blockages or abnormalities that could affect the planned laser treatment.
  • People whose eye pressure, measured at three specific times during a single day (8am, 10am, and 4pm) while on their current medications, falls between 16 mmHg and 30 mmHg.
  • People who undergo the study laser treatment (DSLT) successfully at the baseline visit.

Who may not be able to join:

  • People whose glaucoma in the treated eye was caused by injury, cancer, eye inflammation, abnormal blood vessel growth, or problems with blood circulation.
  • People with significantly reduced side (peripheral) vision, including severe damage to the nerve fibres in the eye.
  • People whose visual field test result shows vision loss beyond a certain level (worse than -20 dB on a standard 24-2 test).
  • People who have previously had incisional glaucoma surgery, argon laser trabeculoplasty (ALT), or minimally invasive glaucoma surgery (MIGS) in the treated eye.
  • People who have had certain eye laser procedures — including iridotomy, selective laser trabeculoplasty (SLT), or MicroPulse Laser Trabeculoplasty — within the past two years.
  • People who are unable to complete a reliable visual field (side vision) test, where too many errors or losses are recorded.
  • People whose optic nerve (the nerve connecting the eye to the brain) shows a cup-to-disc ratio greater than 0.8, indicating significant nerve damage (confirm with trial site).
  • People with certain conditions affecting the tissue around or behind the eye, such as a tumour behind the eye, thyroid eye disease, or Sturge-Weber Syndrome, which can raise pressure in the eye's blood vessels.
  • People with active inflammation, swelling, or certain inherited or acquired conditions affecting the cornea (the clear front surface of the eye) in the treated eye.
  • People who have had a corneal transplant or certain corneal cell replacement procedures in the treated eye.
  • People with significant corneal scarring or surface irregularities, or who are expected to have corneal surgery in the future, in the treated eye.
  • People with a visually significant cataract (clouding of the eye's lens) expected to need surgery within 6 months.
  • People who have had cataract surgery within the 24 months before the screening visit.
  • People who have a certain type of artificial lens implanted inside the eye (anterior chamber intraocular lens or implantable contact lens).
  • People with a cataract that was present from birth or caused by injury (except for a minor, harmless type called Mittendorf dots).
  • People with certain conditions affecting the layer of tissue at the back of the eye (choroid), such as detachment, inflammation, or abnormal blood vessel growth.
  • People with retinal or optic nerve disorders — in either eye — that are unrelated to their glaucoma, such as advanced diabetic eye disease, blocked retinal blood vessels, wet macular degeneration, or advanced dry macular degeneration (mild background diabetic retinopathy is acceptable).
  • People with significant eye damage from past injuries, such as chemical burns or blunt trauma, in the treated eye.
  • People with a history of chronic eye inflammation or currently active eye inflammation (such as uveitis or iritis) in the treated eye.
  • People who have previously had a glaucoma drainage stent (such as an iStent or Hydrus Microstent) inserted into the treated eye.
  • People who have previously received certain implants or drug products injected inside the eye (such as Durysta, Dexycu, or a Travoprost Intraocular Implant) in the treated eye.
  • People for whom, in the treating doctor's judgement, certain implants being studied in the trial would not be safe or appropriate, or who may not be able to follow the study requirements.
  • People whose other (non-study) eye has very poor vision, worse than 20/200 even with glasses.
  • People whose other eye is already enrolled in this trial or another clinical trial.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • People with uncontrolled systemic (whole-body) conditions such as poorly controlled diabetes or high blood pressure that could affect their ability to participate.
  • People with immune system disorders or deficiencies.
  • People who have used steroid medications — in eye drop form, or taken by mouth, injection, or inhaler — within 30 days before the screening visit, or who expect to use them during the study. (Nasal steroid sprays are acceptable, as are steroid creams applied to areas other than the face.)
  • People currently participating in another study, or who have done so within 30 days of the screening visit.
  • People currently using or expected to use certain oral medications (acetazolamide or methazolamide) that lower eye pressure.
  • People who have recently changed a long-term medication that could significantly affect eye pressure, within 30 days before screening, or who expect to change such medication during the study.
  • People with any other eye condition that, in the investigator's opinion, could put them at risk, affect study results, or interfere with their participation.
  • People with a corneal thickness measurement greater than 620 micrometres (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Brian Flowers, MD, Ophthalmology Associates

Phone: (817)332-2020

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Ophthalmology Associates, Fort Worth
Registry
ClinicalTrials.gov
Start date
2 April 2026
Est. completion
3 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in diurnal intraocular pressure (IOP) fluctuation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov