Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

Capsular Tension Ring Clinical Trial

Official title:

Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530473
• Other study ID #: IOL&CTR
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-cataract

Exclusion Criteria:

• preexisting corneal pathology

• small pupil

• glaucoma

• zonular dehiscence

• a history of ocular trauma or surgery

• uveitis

• intraoperative complications

Related Conditions & MeSH terms

• Capsular Tension Ring
• Cataract
• Intraocular Lens Rotation

Intervention

Device:
• capsular tension ring
To insert a capsular tension ring during the cataract surgery

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one hour
Primary	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.	one day
Primary	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.	three days
Primary	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.	one week
Primary	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.	two weeks
Primary	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.	one month
Primary	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.	three months
Primary	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.	three months
Primary	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.	three months
Primary	Residual astigmatism (RAS) at two weeks	RAS after surgery, which was measured as manifest refraction at two weeks	two weeks
Primary	Residual astigmatism (RAS) at one month	RAS after surgery, which was measured as manifest refraction at one month	one month
Secondary	visual acuity (VA) at 1 day	Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks	two weeks
Secondary	visual acuity (VA) at 3 days	Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks	two weeks
Secondary	visual acuity (VA) at 1 weeks	Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks	two weeks
Secondary	visual acuity (VA) at 2 weeks	Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks	two weeks
Secondary	visual acuity (VA) at 1 month	Uncorrected distance visual acuity (UDVA) of participants after surgery at one month	one month
Secondary	visual acuity (VA) at 3 months	Uncorrected distance visual acuity (UDVA) of participants after surgery at three months	three months
Secondary	visual acuity (VA) at 6 months	Uncorrected distance visual acuity (UDVA) of participants after surgery at six months	six months
Secondary	visual acuity (VA) at 12 months	Uncorrected distance visual acuity (UDVA) of participants after surgery at twelve months	twelve months
Secondary	IOL tilt at 1 day	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	one day
Secondary	IOL tilt at 3 days	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	three days
Secondary	IOL tilt at 1 week	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	one week
Secondary	IOL tilt at 2 weeks	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	two weeks
Secondary	IOL tilt at 1 month	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	one month
Secondary	IOL tilt at 3 months	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	three months
Secondary	IOL tilt at 6 months	The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.	six months