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Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

Primary Purpose

Intraocular Lens Rotation, Capsular Tension Ring

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
capsular tension ring
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Lens Rotation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-cataract

Exclusion Criteria:

  • preexisting corneal pathology
  • small pupil
  • glaucoma
  • zonular dehiscence
  • a history of ocular trauma or surgery
  • uveitis
  • intraoperative complications

Sites / Locations

  • Eye & ENT Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CTR Group

NCTR Group

Arm Description

Eyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery.

Eyes underwent cataract surgery without implanting a CTR.

Outcomes

Primary Outcome Measures

IOL rotation degree at one hour
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 day
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 3 days
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 week
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 2 weeks
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 1 month
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 3 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 6 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
IOL rotation degree at 12 months
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Residual astigmatism (RAS) at two weeks
RAS after surgery, which was measured as manifest refraction at two weeks
Residual astigmatism (RAS) at one month
RAS after surgery, which was measured as manifest refraction at one month

Secondary Outcome Measures

visual acuity (VA) at 1 day
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
visual acuity (VA) at 3 days
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
visual acuity (VA) at 1 weeks
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
visual acuity (VA) at 2 weeks
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
visual acuity (VA) at 1 month
Uncorrected distance visual acuity (UDVA) of participants after surgery at one month
visual acuity (VA) at 3 months
Uncorrected distance visual acuity (UDVA) of participants after surgery at three months
visual acuity (VA) at 6 months
Uncorrected distance visual acuity (UDVA) of participants after surgery at six months
visual acuity (VA) at 12 months
Uncorrected distance visual acuity (UDVA) of participants after surgery at twelve months
IOL tilt at 1 day
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at 3 days
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at 1 week
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at 2 weeks
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at 1 month
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at 3 months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
IOL tilt at 6 months
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

Full Information

First Posted
August 30, 2022
Last Updated
April 26, 2023
Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT05530473
Brief Title
Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
Official Title
Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University
Collaborators
National Natural Science Foundation of China

4. Oversight

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

5. Study Description

Brief Summary
This study included cataract patients who underwent intraocular lens (IOL) implantation with or without capsular tension ring (CTR), which aimed to evaluate the contribution of the use of CTR in clinical visual outcomes and rotational stability of IOL after cataract surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Lens Rotation, Capsular Tension Ring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTR Group
Arm Type
Experimental
Arm Description
Eyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery.
Arm Title
NCTR Group
Arm Type
No Intervention
Arm Description
Eyes underwent cataract surgery without implanting a CTR.
Intervention Type
Device
Intervention Name(s)
capsular tension ring
Other Intervention Name(s)
capsular tension ring (ACPi-11; Bausch&Lomb)
Intervention Description
To insert a capsular tension ring during the cataract surgery
Primary Outcome Measure Information:
Title
IOL rotation degree at one hour
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
one hour
Title
IOL rotation degree at 1 day
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
one day
Title
IOL rotation degree at 3 days
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
three days
Title
IOL rotation degree at 1 week
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
one week
Title
IOL rotation degree at 2 weeks
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
two weeks
Title
IOL rotation degree at 1 month
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
one month
Title
IOL rotation degree at 3 months
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
three months
Title
IOL rotation degree at 6 months
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
three months
Title
IOL rotation degree at 12 months
Description
After the pupil was dilated, the IOL axis was recorded by a senior surgeon (C. L.) using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.
Time Frame
three months
Title
Residual astigmatism (RAS) at two weeks
Description
RAS after surgery, which was measured as manifest refraction at two weeks
Time Frame
two weeks
Title
Residual astigmatism (RAS) at one month
Description
RAS after surgery, which was measured as manifest refraction at one month
Time Frame
one month
Secondary Outcome Measure Information:
Title
visual acuity (VA) at 1 day
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Time Frame
two weeks
Title
visual acuity (VA) at 3 days
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Time Frame
two weeks
Title
visual acuity (VA) at 1 weeks
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Time Frame
two weeks
Title
visual acuity (VA) at 2 weeks
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
Time Frame
two weeks
Title
visual acuity (VA) at 1 month
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at one month
Time Frame
one month
Title
visual acuity (VA) at 3 months
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at three months
Time Frame
three months
Title
visual acuity (VA) at 6 months
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at six months
Time Frame
six months
Title
visual acuity (VA) at 12 months
Description
Uncorrected distance visual acuity (UDVA) of participants after surgery at twelve months
Time Frame
twelve months
Title
IOL tilt at 1 day
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
one day
Title
IOL tilt at 3 days
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
three days
Title
IOL tilt at 1 week
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
one week
Title
IOL tilt at 2 weeks
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
two weeks
Title
IOL tilt at 1 month
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
one month
Title
IOL tilt at 3 months
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
three months
Title
IOL tilt at 6 months
Description
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Time Frame
six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: -cataract Exclusion Criteria: preexisting corneal pathology small pupil glaucoma zonular dehiscence a history of ocular trauma or surgery uveitis intraoperative complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Yang, PhD
Organizational Affiliation
Eye & ENT Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

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