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A Multicenter, Observational Cohort Study on the Efficacy and Safety of Phacoemulsification Combined with Goniotomy in Patients with Normal-Tension Glaucoma and Cataract

A Multicenter, Observational Cohort Study on the Efficacy and Safety of Phacoemulsification Combined with Goniotomy in Patients with Normal-Tension Glaucoma and Cataract

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127472
Enrollment
Unknown
Registered
2026-07-01
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

normal-tension glaucoma

Interventions

Patients with Normal-Tension Glaucoma and Cataract Treated with Combined Phacoemulsification and Goniotomy (phaco-GT):None

Sponsors

The Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
36 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients aged >= 36 years, of either sex; 2.Patients diagnosed with Normal-Tension Glaucoma (NTG). Diagnostic Criteria for NTG [19, 20]: (1). Untreated intraocular pressure (IOP) 28 mm and pathological myopia are grounds for exclusion. Therefore, patients with high myopia who are non-pathological, have an axial length <= 28 mm, consistently maintain IOP <= 21 mmHg, and exhibit typical glaucomatous visual field changes are eligible for inclusion); (3). Presence of glaucomatous visual field defects consistent with optic nerve damage; (4). Open anterior chamber angles confirmed by gonioscopy; (5). Exclusion of other ocular diseases (including those causing visual field defects such as congenital or hereditary optic neuropathy; conditions related to optic disc abnormalities like physiological large cup, optic disc coloboma, optic disc drusen, sieve-like defect, or ischemic/compressive optic neuropathy; conditions related to pseudonormal tension glaucoma such as normalization of IOP after discontinuing steroids, or IOP reduction following systemic administration of antihypertensive drugs; and diseases potentially affecting ocular parameter collection including diabetic retinopathy, age-related macular degeneration, ocular trauma, and strabismus); (6). Cranial and orbital contrast-enhanced MRI to exclude visual pathway diseases (required for all enrolled patients, with results valid within one year); 3.Patients with intraocular pressure (IOP) <= 21 mmHg while on 2 to 4 topical antiglaucoma medications (Note: Historical IOP, including any single measurement, multiple measurements, or 24-hour IOP profile, must never have exceeded 21 mmHg at any time point); 4.Patients with visually significant cataract defined as best-corrected visual acuity (BCVA) <= 0.63 measured using the ETDRS chart; 5.For the retrospective cohort: Patients meeting the above criteria who have already undergone phaco-GT surgery, possess complete medical records, and have either completed or are in the process of completing the scheduled follow-up; For the prospective cohort: Patients meeting the above criteria who consent to undergo phaco-GT surgery (Note: Only non-instrument-dependent microsurgical knives are included, e.g., Tanito microhook (TMH), Lanxin trabecular meshwork knife, Zeng's trabecular meshwork knife (TMK), or bent 25G/26G needles (BANG technique); cases utilizing the Kahook Dual Blade (KDB) are excluded); 6.Patients who voluntarily participate in the study, provide signed informed consent, and agree to adhere to the study follow-up schedule.

Exclusion criteria

Exclusion criteria: 1.Patients with any history of intraocular surgery or ocular trauma; 2.Patients with concomitant other types of glaucoma, including primary angle-closure glaucoma, juvenile open-angle glaucoma (defined as disease onset before 36 years of age; patients meeting age criteria but with early onset are excluded), and various secondary glaucomas (including secondary angle-closure, pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, pseudoexfoliation syndrome, etc.); 3.Patients with severe ocular comorbidities affecting the acquisition of ocular parameters or interfering with visual field testing; 4.Pregnant or lactating women, or those planning pregnancy in the near future; 5.Patients with severe anxiety or depression, or those diagnosed with psychiatric disorders; 6.Patients with axial length > 28 mm or pathological myopia.

Design outcomes

Primary

MeasureTime frame
Number and classes of topical hypotensive medications;

Secondary

MeasureTime frame
Demographic data and medical history;Documentation of Complications;Refraction and Visual Acuity Assessment;Slit-lamp examination;Systemic Adverse Event Collection;Ocular Biometry;MRI of the Brain and Orbits;Visual Field Testing;Adverse Event Collection;Intraocular pressure;

Countries

China

Contacts

Public ContactXiulan Zhang

The Zhongshan Ophthalmic Center,Sun Yat-sen University

xiulan_z@qq.com+86 20 66610720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026