Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia

Peking University

Status: Unknown

Conditions: Cataract Senile; Presbyopia

Treatments: Device: monofocal IOL; Device: different IOLs; Device: trifocal IOL; Device: EDOF IOL; Device: mix bifocal IOL; Device: bifocal IOL

Study type: Observational

Funder types: Other

Identifiers

NCT04265846

20191129

Details and patient eligibility

About

Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia.

Full description

Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens Implantation designed for the correction of presbyopia.The subjects will undergo bilateral uneventful phacoemulsification and implantation of IOL.The subjects will be divided into several groups according to the type of the IOLs，including monofocal IOL group,monovision designed group ，bifocal IOL group, mix bifocal IOL group，trifocal IOL group，Exteded Depth of Focus(EDOF) IOL group and blend vision group. Compare the Subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.

Enrollment: 140 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with bilateral cataract
• 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.

Trial design

140 participants in 7 patient groups

bifocal IOL group

Description:

The cataract patients who ask for bilateral phacoemulsification and bifocal IOLs implantation.

Treatment:

Device: bifocal IOL

mix bifocal IOL group

Description:

The cataract patients who ask for phacoemulsification and mix different bifocal IOLs implantation bilaterally

Treatment:

Device: mix bifocal IOL

trifocal IOL group

Description:

The cataract patients who ask for bilateral phacoemulsification and trifocal IOLs implantation.

Treatment:

Device: trifocal IOL

EDOF IOL group

Description:

The cataract patients who ask for bilateral phacoemulsification and EDOF IOLs implantation.

Treatment:

Device: EDOF IOL

blend vision group

Description:

The cataract patients who ask for phacoemulsification and different IOLs implantation bilaterally.

Treatment:

Device: different IOLs

monovision designed group

Description:

The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.

Treatment:

Device: monofocal IOL

Device: monofocal IOL

monofocal IOL group

Description:

The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.

Treatment:

Device: monofocal IOL

Device: monofocal IOL