Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

NCT ID: NCT04266847

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2020-09-01

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.

Conditions

Cataract Senile

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

unilateral mild cataract patients

The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye.

Group Type: EXPERIMENTAL

monofocal IOL,bifocal IOL,or trifocal IOL

Intervention Type: DEVICE

phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL

Interventions

monofocal IOL,bifocal IOL,or trifocal IOL

phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qi Hong, PhD，MD

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

QIanqian Lan

Role: CONTACT

54283122@qq.com

+8618607711972

Facility Contacts

Hong Qi, MD

Role: primary

doctorqihong@163.com

Other Identifiers

20191127

Identifier Type: -

Identifier Source: org_study_id