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Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

Primary Purpose

Cataract Senile

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
monofocal IOL,bifocal IOL,or trifocal 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 Senile 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 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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

unilateral mild cataract patients

Arm Description

The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye.

Outcomes

Primary Outcome Measures

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 29, 2019
Last Updated
February 10, 2020
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04266847
Brief Title
Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients
Official Title
Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
September 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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
unilateral mild cataract patients
Arm Type
Experimental
Arm Description
The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye.
Intervention Type
Device
Intervention Name(s)
monofocal IOL,bifocal IOL,or trifocal IOL
Intervention Description
phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL
Primary Outcome Measure Information:
Title
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 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.
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

Learn more about this trial

Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

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