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

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
unilateral implantation of IOL
bilateral implantation of IOL
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

The 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.

The 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
stereopsis
Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.
Fusion function
The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.
Subjective visual quality
Photic phenomena (score according to severity,0~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.

Full Information

First Posted
November 26, 2019
Last Updated
February 10, 2020
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04265820
Brief Title
Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
Official Title
Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
The 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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
The 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.
Intervention Type
Device
Intervention Name(s)
unilateral implantation of IOL
Intervention Description
unilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
Intervention Type
Device
Intervention Name(s)
bilateral implantation of IOL
Intervention Description
bilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
Primary Outcome Measure Information:
Title
monocular and binocular visual acuity
Description
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
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Binocular Contrast sensitivity
Description
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.
Time Frame
3 months postoperatively
Title
Binocular Defocus Curve
Description
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.
Time Frame
3 months postoperatively
Title
stereopsis
Description
Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.
Time Frame
3 months postoperatively
Title
Fusion function
Description
The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.
Time Frame
3 months postoperatively
Title
Subjective visual quality
Description
Photic phenomena (score according to severity,0~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by questionnaire.
Time Frame
3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianqian Lan
Phone
+8618607711972
Email
54283122@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Hong, PhD，MD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Qi, MD
Email
doctorqihong@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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