Capsular Tension Ring, Intraocular Lens Rotation
Conditions
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.
Interventions
DEVICEcapsular tension ring
To insert a capsular tension ring during the cataract surgery
Sponsors
National Natural Science Foundation of China
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
-cataract
Exclusion criteria
* preexisting corneal pathology * small pupil * glaucoma * zonular dehiscence * a history of ocular trauma or surgery * uveitis * intraoperative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| visual acuity (VA) at 1 day | two weeks | Uncorrected distance visual acuity (UDVA) of participants after surgery at two weeks |
| 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 3 months | three months | 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 |
| 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 |
| 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 |
| IOL tilt at 1 day | one day | The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer. |
| 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. |
Countries
China
Outcome results
None listed