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Clinical study of the Ab Interno Trabeculotomy in Angle-Closure Glaucoma

Clinical study of the Ab Interno Trabeculotomy with KDB in Angle-Closure Glaucoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030065
Enrollment
Unknown
Registered
2020-02-22
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

primary angle-closure glaucoma

Interventions

Group1:phacoemulsificaiton and IOL and goniosynechialysis implantation
Group1:ab interno trabeculectomy

Sponsors

Changsha Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Part I inclusion criteria 1. Aged >= 40 years; 2. Diagnosis of Primary Angle Closure or primary angle closure glaucoma; 3. More than or equal to 180 degrees of PAS (not necessarily contiguous); 4. IOP > 21 mmHg if untreated or 21 mmHg if untreated or <= 21 mmHg on topical medication; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: Part I exclusion criteria were: 1. Previous intraocular surgery (except laser iridotomy was allowed) and previous refractive corneal surgery; 2. Previous tramatic damage of aqueous humor drainage system in the anterior chamber (such as recession of chamber Angle); 3. Evidence of moderate non-proliferative diabetic retinopathy, neovascularization, or rubeosis iridis, uveitis, retinitis pigmentosa, occlusion of retinal vessels and dislocation of the lens; 4. Serious ocular surface diseases which affect the use of gonioscope; 5. Chronic use of topical or systemic steroids and allergic to sulfanilamide; 6. Advanced glaucoma with severe visual field (VF) defect, defined as visual field deficit threatening fixation; 7. Surgical complications including: no IOL implantation, rupture of posterior capsule and anterior vitrectomy; 8. Patients were unable to complete the follow-up for 6 months; Part II exclusion criteria were: 1. Previous intraocular surgery (except laser iridotomy and trabeculectomy were allowed) and previous refractive corneal surgery; 2. Previous tramatic damage of aqueous humor drainage system in the anterior chamber (such as recession of chamber Angle); 3. Evidence of moderate non-proliferative diabetic retinopathy, neovascularization, or rubeosis iridis ,uveitis, retinitis pigmentosa, occlusion of retinal vessels and dislocation of the lens; 4. Serious ocular surface diseases which affect the use of gonioscope; 5. Anticoagulants, INR > 3.0 within a week before surgery; 6. Chronic use of topical or systemic steroids and allergic to sulfanilamide; 7. Patients were unable to complete the follow-up for at least 6 months.

Design outcomes

Primary

MeasureTime frame
intraocular pressure;

Secondary

MeasureTime frame
the number of anti-glaucoma eye drop;visual acuity;complications during follow up period;ocular parameters of anterior chamber;

Countries

China

Contacts

Public ContactLin Ding

Aier School of Opthalmology, Central South University

dlinoph@163.com+86 13787255158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026