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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265820
• Other study ID #: 20191126
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2020
• Source: Peking University Third Hospital
• Contact: Qianqian Lan
• Phone: +8618607711972
• Email: 54283122[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with unilateral or bilateral age related cataracts

• 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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• unilateral implantation of IOL
unilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal,according to the patients preference and the eyes condition.
• bilateral implantation of IOL
bilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal,according to the patients preference and the eyes condition.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monocular and binocular visual acuity	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	3 months postoperatively
Secondary	Binocular Contrast sensitivity	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.	3 months postoperatively
Secondary	Binocular Defocus Curve	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.	3 months postoperatively
Secondary	stereopsis	Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.	3 months postoperatively
Secondary	Fusion function	The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.	3 months postoperatively
Secondary	Subjective visual quality	Photic phenomena (score according to severity,0~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.	3 months postoperatively