Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients

Peking University

Status: Unknown

Conditions: Cataract

Treatments: Device: bilateral implantation of IOL; Device: unilateral implantation of IOL

Study type: Interventional

Funder types: Other

Identifiers

NCT04265820

20191126

Details and patient eligibility

About

This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.

Full description

The subjects will undergo uneventful phacoemulsification and implantation of IOL.

The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unilateral or bilateral age related cataracts
• Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter

Exclusion criteria

• Pregnant or nursing women
• In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
• Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
• History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
• Patients with history of ocular trauma or prior ocular surgery including refractive procedures
• postoperative visual acuity of worse than 0.2 logMAR in any eye
• Patients using systemic or ocular medication that affect visual acuity.
• Patients participating in other clinical trials during the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group 1

Experimental group

Description:

The unilateral cataract patients in the Group 1 will undergo phacoemulsification and unilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs.

Treatment:

Device: unilateral implantation of IOL

Group 2

Active Comparator group

Description:

The bilateral cataract patients in the Group 2 will undergo phacoemulsification and bilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs.

Treatment:

Device: bilateral implantation of IOL