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Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

P

Peking University

Status

Unknown

Conditions

Cataract Senile

Treatments

Device: monofocal IOL,bifocal IOL,or trifocal IOL

Study type

Interventional

Funder types

Other

Identifiers

NCT04266847
20191127

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

unilateral mild cataract patients
Experimental group
Description:
The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye.
Treatment:
Device: monofocal IOL,bifocal IOL,or trifocal IOL

Trial contacts and locations

1

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Central trial contact

QIanqian Lan

Data sourced from clinicaltrials.gov

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