Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

Not Applicable

• Conditions: Cataract Senile
• Interventions: Device: monofocal IOL,bifocal IOL,or trifocal IOL

• Registration Number: NCT04266847
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.

Detailed Description

The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2019-11-29
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-06-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
• Regular corneal topography and 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.)
• In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)
• Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
• Patients using systemic or ocular medication that affect visual acuity.
• Patients with history of ocular trauma or prior ocular surgery including refractive procedures
• Patients participating in other clinical trials during the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
unilateral mild cataract patients	monofocal IOL,bifocal IOL,or trifocal IOL	The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye.

Primary Outcome Measures

Name	Time	Method
binocular visual acuity	3 months postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Binocular Contrast sensitivity	3 months postoperatively	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
Binocular Defocus Curve	3 months postoperatively	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.
stereopsis	3 months postoperatively	Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.
Fusion function	3 months postoperatively	The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.
Subjective visual quality	3 months postoperatively	Photic phenomena (score according to severity,0\~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China