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New treatment option for Primary Open Angle Glaucoma and Cataracts
Official title PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract
ClinicalTrials.gov ID: NCT07700498
What this study is testing
What is PEI combined with gonioscopy-assisted trabeculotomy?
PEI combined with gonioscopy-assisted trabeculotomy is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for primary open angle glaucoma and cataracts.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn whether doing phacoemulsification combined with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the burden of glaucoma eye drops in adults with primary open-angle glaucoma and cataract. It will also learn whether this early surgical strategy improves ocular surface health and vision-related quality of life.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- Provides written informed consent voluntarily.
- Age 40 to 85 years.
- Male or female.
- Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery.
- Lens opacity causing decreased visual quality and clinically significant cataract.
You likely can't join if
- Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.
- Angle-closure glaucoma or narrow angle inconsistent with POAG.
- POAG without visually significant cataract.
- Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.
- Advanced visual field loss, defined as visual field mean deviation worse than -12 dB.
- Severe ocular comorbidity or inability to perform reliable visual acuity testing.
See the full eligibility criteria
- Provides written informed consent voluntarily.
- Age 40 to 85 years.
- Male or female.
- Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery.
- Lens opacity causing decreased visual quality and clinically significant cataract.
- Diagnosis of POAG combined with cataract by the treating ophthalmologist.
- Best-corrected visual acuity of 0.1 or better on the Snellen chart, corresponding to LogMAR 1.0 or less.
- Ability and willingness to complete scheduled follow-up visits and study examinations.
- Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.
- Angle-closure glaucoma or narrow angle inconsistent with POAG.
- POAG without visually significant cataract.
- Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.
- Advanced visual field loss, defined as visual field mean deviation worse than -12 dB.
- Severe ocular comorbidity or inability to perform reliable visual acuity testing.
- Known contraindication to required study medications.
- Average RNFL thickness or GCIPL thickness less than 54 micrometers.
- Axial length greater than 26 mm.
- Monocular status or functional vision in only one eye.
- Inability to complete reliable visual field or OCT testing.
- Systemic disease that may affect ocular status or study assessment, including diabetes mellitus, uncontrolled hypertension, malignancy, renal disease, autoimmune disease, neurological disease, liver disease...
- Visual impairment mainly attributable to disease other than POAG or cataract.
- Pregnancy, lactation, or planned pregnancy during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Ningxia, Ningxia, China
- Guangzhou, China
- Luzhou, China
- Zhengzhou, China
- Zhuhai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ningxia, Ningxia, China; Guangzhou, China; Luzhou, China; Zhengzhou, China; Zhuhai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.