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A Pilot Study on the Safety and Preliminary Efficacy of a Small-Aperture Intraocular Lens in High-Risk Malignant Glaucoma Patients

A Pilot Study on the Safety and Preliminary Efficacy of a Small-Aperture Intraocular Lens in High-Risk Malignant Glaucoma Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115223
Enrollment
Unknown
Registered
2025-12-24
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Glaucoma

Interventions

Intraocular lens implantation group:The intervention involves cataract extraction combined with small-aperture intraocular lens (IOL) implantation. Depending on the patient’s ocular condition and path

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with complex, refractory, or high-risk ocular conditions, including but not limited to: Advanced glaucoma refractory to conventional therapy. Acute primary angle-closure glaucoma (in the attack phase). Established malignant glaucoma. Nanophthalmos (with or without secondary glaucoma). Anatomical predisposition (e.g., short axial length, shallow anterior chamber) conferring a high risk of malignant glaucoma. 2. Clinically significant cataract planned for surgical removal. 3. Age between 18 and 75 years. 4. Willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients deemed by the investigator to have systemic diseases (e.g., Sjögren's syndrome) that may increase surgical risk or compromise postoperative outcomes. 2. Patients using systemic or ocular medications (e.g., chlorpromazine, ethambutol, digitalis, chloroquine) that, in the investigator's judgment, may confound study results or pose additional risk to the subject. 3. Patients with traumatic cataract or bilateral congenital cataract. 4. Women who are pregnant, lactating, planning a pregnancy in the near future, or who have other conditions associated with hormonal fluctuations. 5. Participation in another investigational medical device trial within 30 days prior to screening, or in an investigational drug trial within 3 months prior to screening. 6. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Intraocular pressure;Visual acuity;Anterior chamber depth;

Secondary

MeasureTime frame
Visual quality;

Countries

China

Contacts

Public ContactXiaojie Wang

Eye Hospital of Wenzhou Medical University

xiaojiewang18@yeah.net+86 150 5778 3433

Outcome results

None listed

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