Early combined cataract and glaucoma surgery for POAG and cataract

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with both primary open-angle glaucoma and cataract are randomized to receive phacoemulsification with gonioscopy-assisted trabeculotomy or phacoemulsification with standard glaucoma eye drops. The study compares long-term medication use, ocular surface health, vision-related quality of life, and safety after initial treatment. Follow-up visits occur at multiple time points up to 24 months to assess outcomes. Outcome assessors are masked when feasible to reduce bias.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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, cardiovascular disease, or systemic inflammatory disease.
* Visual impairment mainly attributable to disease other than POAG or cataract.
* Pregnancy, lactation, or planned pregnancy during the study period.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, China Recruiting
• People's Hospital of Ningxia Hui Autonomous Region
  Ningxia, Ningxia, China Not yet recruiting
• The Affiliated Hospital of Southwest Medical University
  Luzhou, China Not yet recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, China Not yet recruiting
• Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
  Zhuhai, China Not yet recruiting

Study contacts

• Study coordinator: Hongyang Zhang, PhD
• Email: hy3005716@163.com
• Phone: +86-20-62787325

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.