MedPath

Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients

Not Applicable
Conditions
Cataract
Interventions
Device: bilateral implantation of IOL
Device: unilateral implantation of IOL
Registration Number
NCT04265820
Lead Sponsor
Peking University Third Hospital
Brief Summary

This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens(IOLs) in cataract patients.

Detailed Description

The subjects will undergo uneventful phacoemulsification and implantation of IOL.

The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal,according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Patients with unilateral or bilateral age related cataracts
  • Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 2bilateral implantation of IOLThe bilateral cataract patients in the Group 2 will undergo phacoemulsification and bilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs.
Group 1unilateral implantation of IOLThe unilateral cataract patients in the Group 1 will undergo phacoemulsification and unilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs.
Primary Outcome Measures
NameTimeMethod
monocular and binocular visual acuity3 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
NameTimeMethod
Fusion function3 months postoperatively

The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.

Binocular Contrast sensitivity3 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.

Subjective visual quality3 months postoperatively

Photic phenomena (score according to severity,0\~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.

Binocular Defocus Curve3 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.

stereopsis3 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.

Trial Locations

Locations (1)

Peking University Third Hospital

🇨🇳

Beijing, Beijing, China

© Copyright 2025. All Rights Reserved by MedPath