Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

Study Overview
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Brief Summary
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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.

Official Title
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Combined Capsular Tension Ring and IOL Implantation for Management of Cataracts

Conditions
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Intraocular Lens Rotation, Capsular Tension Ring

Intervention / Treatment
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* Device: capsular tension ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -cataract Exclusion Criteria: preexisting corneal pathology small pupil glaucoma zonular dehiscence a history of ocular trauma or surgery uveitis intraoperative complications
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTR Group<br>Eyes had a capsular tension ring (CTR) implanted into the capsular bag during the cataract surgery. | Device: capsular tension ring<br>* To insert a capsular tension ring during the cataract surgery<br>* Other names: capsular tension ring (ACPi-11; Bausch&Lomb);|
| No Intervention: NCTR Group<br>Eyes underwent cataract surgery without implanting a CTR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Residual astigmatism (RAS) at two weeks | RAS after surgery, which was measured as manifest refraction at two weeks | two weeks | 
| Residual astigmatism (RAS) at one month | RAS after surgery, which was measured as manifest refraction at one month | one month | 

Secondary Outcome Measures

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