Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

Not Applicable

Completed

• Conditions: Intraocular Lens Rotation; Capsular Tension Ring
• Interventions: Device: capsular tension ring

• Registration Number: NCT05530473
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Primary Completion: 2022-12-01
• Study Completion: 2023-03-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

-cataract

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
IOL rotation degree at 12 months	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.
Residual astigmatism (RAS) at two weeks	two weeks	RAS after surgery, which was measured as manifest refraction at two weeks
Residual astigmatism (RAS) at one month	one month	RAS after surgery, which was measured as manifest refraction at one month
IOL rotation degree at 1 week	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.
IOL rotation degree at 2 weeks	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.
IOL rotation degree at 1 month	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.
IOL rotation degree at 3 months	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.
IOL rotation degree at one hour	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	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.
IOL rotation degree at 3 days	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.
IOL rotation degree at 6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China