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To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism
This single-center, single-blinded, prospective, randomized controlled trial was performed at two sites of Kazakh Eye Research Institute.
Children with pediatric cataract and corneal astigmatism were included and randomized to two groups for pediatric cataract surgery with toric and non-toric intraocular lens (IOL) implantation. The uncorrected and corrected distance visual acuity, near visual acuity, keratometry data, and residual astigmatism were evaluated.
The purpose of this study is to evaluate the visual and refractive outcomes after a toric IOL implantation in pediatric eyes with cataract and preexisting corneal astigmatism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric | Experimental | A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx |
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| Non-toric | Active Comparator | A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| congenital/pediatric cataract surgery | Procedure | All procedures are performed under general anesthesia according to the standard technique of congenital/pediatric cataract surgery with an intraocular lens (IOL) implantation. Paracentesis is performed at 2.30 o'clock using a 20-gauge straight microvitreoretinal (MVR) knife; a high molecular weight ophthalmic viscosurgical devices (OVD) is injected into the anterior chamber. Then a 2.4 mm corneal tunnel incision is made at 11 o'clock with a disposable keratome knife 2.2 mm. Circular continuous capsulorhexis (≈ 5.5 mm). Сortical cleaving hydrodissection is followed by bimanual phacoaspiration in irrigation-aspiration mode. OVD is injected in the anterior chamber and an IOL is implanted in the capsular bag. Residual OVD is aspirated from the anterior chamber and behind the IOL and followed by IOL alignment. The surgery is completed with corneal hydration at the tunnel incision site. |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity | measured using the Lea symbol visual acuity chart or the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart according to the patient's age | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) |
| Uncorrected (UCNVA) and corrected (CNVA) near visual acuity | measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient's age | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) |
| Refraction measurements | obtained with KR-1W Wavefront Analyzer | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) |
| Measure | Description | Time Frame |
|---|---|---|
| Keratometry measurements | obtained with KR-1W Wavefront Analyzer | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kairat Ruslanuly, MD | Kazakh Eye Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kazakh Eye Research Institute | Almaty | 050012 | Kazakhstan | |||
| Kazakh Eye Research Institute |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Non-Toric IOLs | Device | A folding hydrophobic acrylic IOLs AcrySof IQ SN60WF and Clareon SY60WF for the non-toric group (Alcon Laboratories, Inc.) ARE implanted. |
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| Toric IOLs | Device | A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx for the toric group (Alcon Laboratories, Inc.) were implanted. |
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| Astana |
| 010000 |
| Kazakhstan |