Clinical Safety and Efficacy of Crosslinked Polyisobutylene Polymer Intraocular Lens

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17013797

Enrollment

Unknown

Registered

2017-12-06

Start date

2018-03-01

Completion date

Unknown

Last updated

2017-12-11

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

Conditions

patients with cataract

Interventions

1:Crosslinked Polyisobutylene IOL

2:Hydrophobic Acrylate Polymer IOL

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 18 years, gender is not limited; 2. Monocular or binocular cataracts; 3. The best corrected visual acuity before operation was = 20 / 40; 4. The number of corneal endothelial cells before operation = 2000/mm2; 5. The pupil diameter is 2.5 mm ~ 4 mm before operation; 6. The depth of anterior chamber is = 2.00 mm before operation; 7. The axial length of the eye is 21 mm ~ 26 mm before operation; 8. Preoperative astigmatism degree = 1.5d.

Exclusion criteria

Exclusion criteria: 1. Corneal abnormality; 2. Pseudoexfoliation; 3. Preceding ocular surgery or trauma; 4. Uncontrolled glaucoma; 5. Proliferative diabetic retinopathy; 6. Iris neovascularization; History of uveitis/iritis; 7. Microphthalmus; Recurrent intraocular inflammation of unknown etiology; 8. Uncontrolled systemic or ocular disease; 9. Pregnancy.

Design outcomes

Primary

Measure	Time frame
the rate of complication;the inflammation after IOL implantation;the stablity after IOL implantation;the far/middle/near vision;vision quality;questionnaire;	—

Countries

China

Contacts

Public ContactYune Zhao

The Eye Hospital of Wenzhou Medical University

zye@mail.eye.cn+86 13819707056

Outcome results

None listed

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