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

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

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Device: unilateral implantation of IOL; Device: bilateral implantation of IOL

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: QIanqian Lan; Phone Number: +8618607711972; Email: 54283122@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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.	Device: unilateral implantation of IOL; unilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
Active Comparator: Group 2; 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.	Device: bilateral implantation of IOL; bilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monocular and binocular visual acuity	uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Contrast sensitivity	Contrast sensitivity measures will be conducted binocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity will be evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree [cpd]). Patients will be allowed 5 minutes to adapt to each illumination level before testing.	3 months postoperatively
Binocular Defocus Curve	Binocular defocus curves will be obtained in all patients, positioned at 5m under photopic (>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity will be recorded for each type of defocus level. The procedure will be then repeated but with positive lenses. The range of defocus evaluated is from -4.00D to +2.00D.	3 months postoperatively
stereopsis	Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.	3 months postoperatively
Fusion function	The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.	3 months postoperatively
Subjective visual quality	Photic phenomena (score according to severity,0~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Qi Hong, PhD，MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: unilateral cataract; binocular functional vision; Multifocal Intraocular Lenses
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 20191126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No