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Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04266847
Enrollment
60
Registered
2020-02-12
Start date
2019-10-30
Completion date
2020-09-01
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Senile

Keywords

unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses

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.

Interventions

DEVICEmonofocal IOL,bifocal IOL,or trifocal IOL

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
binocular visual acuity3 months postoperativelyuncorrected 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

MeasureTime frameDescription
Binocular Contrast sensitivity3 months postoperativelyContrast 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 Curve3 months postoperativelyBinocular 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.
stereopsis3 months postoperativelyUse block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.
Fusion function3 months postoperativelyThe fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.
Subjective visual quality3 months postoperativelyPhotic phenomena (score according to severity,0\ 4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.

Countries

China

Contacts

Primary ContactQIanqian Lan
54283122@qq.com+8618607711972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026