Clinical trial NCT04265820: Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
Official title: Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: unilateral cataract
binocular functional vision
Multifocal Intraocular Lenses
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: monocular and binocular visual acuity
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Binocular Contrast sensitivity
timeFrame: 3 months postoperatively
measure: Binocular Defocus Curve
timeFrame: 3 months postoperatively
measure: stereopsis
timeFrame: 3 months postoperatively
measure: Fusion function
timeFrame: 3 months postoperatively
measure: Subjective visual quality
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qi Hong, PhD，MD
role: STUDY_DIRECTOR
References: