Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts
April 26, 2023 updated by: Jin Yang, Eye & ENT Hospital of Fudan University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200031
- Eye & ENT Hospital of Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Study Population
patients underwent underwent IOL implantation with or without CTR
Description
Inclusion Criteria:
-cataract
Exclusion Criteria:
- preexisting corneal pathology
- small pupil
- glaucoma
- zonular dehiscence
- a history of ocular trauma or surgery
- uveitis
- intraoperative complications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CTR Group
Eyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery.
|
To insert a capsular tension ring during the cataract surgery
Other Names:
|
|
No Intervention: NCTR Group
Eyes underwent cataract surgery without implanting a CTR.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IOL rotation degree at one hour
Time Frame: 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.
|
one hour
|
|
Residual astigmatism (RAS) at two weeks
Time Frame: two weeks
|
RAS after surgery, which was measured as manifest refraction at two weeks
|
two weeks
|
|
Residual astigmatism (RAS) at one month
Time Frame: one month
|
RAS after surgery, which was measured as manifest refraction at one month
|
one month
|
|
IOL rotation degree at 1 day
Time Frame: one 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.
|
one day
|
|
IOL rotation degree at 3 days
Time Frame: three 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.
|
three days
|
|
IOL rotation degree at 1 week
Time Frame: one 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.
|
one week
|
|
IOL rotation degree at 2 weeks
Time Frame: two 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.
|
two weeks
|
|
IOL rotation degree at 1 month
Time Frame: one 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.
|
one month
|
|
IOL rotation degree at 3 months
Time Frame: three 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.
|
three months
|
|
IOL rotation degree at 6 months
Time Frame: three 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.
|
three months
|
|
IOL rotation degree at 12 months
Time Frame: three 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.
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual acuity (VA) at 1 day
Time Frame: two weeks
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
|
two weeks
|
|
visual acuity (VA) at 3 days
Time Frame: two weeks
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
|
two weeks
|
|
visual acuity (VA) at 1 weeks
Time Frame: two weeks
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
|
two weeks
|
|
visual acuity (VA) at 2 weeks
Time Frame: two weeks
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks
|
two weeks
|
|
visual acuity (VA) at 1 month
Time Frame: one month
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at one month
|
one month
|
|
visual acuity (VA) at 3 months
Time Frame: three months
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at three months
|
three months
|
|
visual acuity (VA) at 6 months
Time Frame: six months
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at six months
|
six months
|
|
visual acuity (VA) at 12 months
Time Frame: twelve months
|
Uncorrected distance visual acuity (UDVA) of participants after surgery at twelve months
|
twelve months
|
|
IOL tilt at 1 day
Time Frame: one day
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
one day
|
|
IOL tilt at 3 days
Time Frame: three days
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
three days
|
|
IOL tilt at 1 week
Time Frame: one week
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
one week
|
|
IOL tilt at 2 weeks
Time Frame: two weeks
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
two weeks
|
|
IOL tilt at 1 month
Time Frame: one month
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
one month
|
|
IOL tilt at 3 months
Time Frame: three months
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
three months
|
|
IOL tilt at 6 months
Time Frame: six months
|
The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jin Yang, PhD, Eye & ENT Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
March 30, 2023
Study Registration Dates
First Submitted
August 30, 2022
First Submitted That Met QC Criteria
September 2, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOL&CTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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