Cataract
Conditions
Keywords
age related cataract, phacoemulsification, anterior capsule polishing, optical coherence tomography, anterior chamber depth
Brief summary
* The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD) * patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.
Interventions
PROCEDUREanterior capsule polishing
polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* bilateral age-related cataract * good overall physical constitution * uneventful surgeries of both eyes with in-the-bag IOL implantation
Exclusion criteria
* history of intraocular surgery or laser therapy * history of ocular trauma or ocular disease * high myopia * diabetes * severe retinal pathology * patients who could not return on time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Lens Position | 1 day，1 week, 1 month，3 months and 6 months postoperatively | Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity(UCVA) | 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively | The UCVA was recorded in logMAR units at each vist |
| Refractive Error | 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively | auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cataract | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Cataract |
|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment China | 20 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Effective Lens Position
Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.
Time frame: 1 day，1 week, 1 month，3 months and 6 months postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Effective Lens Position | ELP 1 month postoperative | 3.97 mm | Standard Deviation 0.23 |
| Control | Effective Lens Position | the root mean square of changes in the ELP(ELPrms) | 0.06 mm | Standard Deviation 0.02 |
| Control | Effective Lens Position | ELP 3 months postoperative | 3.98 mm | Standard Deviation 0.24 |
| Control | Effective Lens Position | ELP 1 week postoperative | 3.93 mm | Standard Deviation 0.25 |
| Control | Effective Lens Position | ELP 6 months postoperative | 3.92 mm | Standard Deviation 0.25 |
| Control | Effective Lens Position | ELP 1 day postoperative | 3.97 mm | Standard Deviation 0.27 |
| Anterior Capsule Polishing | Effective Lens Position | ELP 6 months postoperative | 3.97 mm | Standard Deviation 0.28 |
| Anterior Capsule Polishing | Effective Lens Position | ELP 1 day postoperative | 4.02 mm | Standard Deviation 0.32 |
| Anterior Capsule Polishing | Effective Lens Position | ELP 1 week postoperative | 3.99 mm | Standard Deviation 0.29 |
| Anterior Capsule Polishing | Effective Lens Position | ELP 1 month postoperative | 3.99 mm | Standard Deviation 0.26 |
| Anterior Capsule Polishing | Effective Lens Position | ELP 3 months postoperative | 3.97 mm | Standard Deviation 0.27 |
| Anterior Capsule Polishing | Effective Lens Position | the root mean square of changes in the ELP(ELPrms) | 0.05 mm | Standard Deviation 0.02 |
Secondary
Refractive Error
auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.
Time frame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Refractive Error | the refractive error 1 week postoperative | -0.42 diopter(D) | Standard Deviation 0.26 |
| Control | Refractive Error | the refractive error 1 day postoperative | -0.33 diopter(D) | Standard Deviation 0.18 |
| Control | Refractive Error | the refractive error 1 month postoperative | -0.37 diopter(D) | Standard Deviation 0.24 |
| Control | Refractive Error | the refractive error 6 months postoperative | -0.41 diopter(D) | Standard Deviation 0.22 |
| Control | Refractive Error | the refractive error 3 month postoperative | -0.36 diopter(D) | Standard Deviation 0.23 |
| Anterior Capsule Polishing | Refractive Error | the refractive error 6 months postoperative | -0.48 diopter(D) | Standard Deviation 0.21 |
| Anterior Capsule Polishing | Refractive Error | the refractive error 3 month postoperative | -0.48 diopter(D) | Standard Deviation 0.22 |
| Anterior Capsule Polishing | Refractive Error | the refractive error 1 day postoperative | -0.45 diopter(D) | Standard Deviation 0.18 |
| Anterior Capsule Polishing | Refractive Error | the refractive error 1 week postoperative | -0.53 diopter(D) | Standard Deviation 0.44 |
| Anterior Capsule Polishing | Refractive Error | the refractive error 1 month postoperative | -0.46 diopter(D) | Standard Deviation 0.47 |
Secondary
Uncorrected Visual Acuity(UCVA)
The UCVA was recorded in logMAR units at each vist
Time frame: 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Uncorrected Visual Acuity(UCVA) | UCVA 1 week postoperative | 0.08 logMAR | Standard Deviation 0.09 |
| Control | Uncorrected Visual Acuity(UCVA) | UCVA 3 months postoperative | 0.10 logMAR | Standard Deviation 0.12 |
| Control | Uncorrected Visual Acuity(UCVA) | UCVA 1 month postoperative | 0.09 logMAR | Standard Deviation 0.1 |
| Control | Uncorrected Visual Acuity(UCVA) | UCVA 6 months postoperative | 0.10 logMAR | Standard Deviation 0.11 |
| Control | Uncorrected Visual Acuity(UCVA) | UCVA 1 day postoperative | 0.07 logMAR | Standard Deviation 0.1 |
| Anterior Capsule Polishing | Uncorrected Visual Acuity(UCVA) | UCVA 6 months postoperative | 0.10 logMAR | Standard Deviation 0.08 |
| Anterior Capsule Polishing | Uncorrected Visual Acuity(UCVA) | UCVA 1 day postoperative | 0.07 logMAR | Standard Deviation 0.09 |
| Anterior Capsule Polishing | Uncorrected Visual Acuity(UCVA) | UCVA 1 week postoperative | 0.08 logMAR | Standard Deviation 0.09 |
| Anterior Capsule Polishing | Uncorrected Visual Acuity(UCVA) | UCVA 1 month postoperative | 0.08 logMAR | Standard Deviation 0.09 |
| Anterior Capsule Polishing | Uncorrected Visual Acuity(UCVA) | UCVA 3 months postoperative | 0.10 logMAR | Standard Deviation 0.08 |