Astigmatism, Cataract Congenital, IOL
Conditions
Keywords
Cataract Congenital, Astigmatism, Toric IOL
Brief summary
To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism
Detailed description
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.
Interventions
PROCEDUREcongenital/pediatric cataract surgery
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.
DEVICENon-Toric IOLs
A folding hydrophobic acrylic IOLs AcrySof IQ SN60WF and Clareon SY60WF for the non-toric group (Alcon Laboratories, Inc.) ARE implanted.
DEVICEToric IOLs
A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx for the toric group (Alcon Laboratories, Inc.) were implanted.
Sponsors
Kazakh Eye Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Visually significant cataract; 2. Corneal astigmatism more than 1.25 diopters; 3. Children aged ≥ 6 years and \< 18 years.
Exclusion criteria
1. Patients with a corneal diameter less than 9 mm; 2. Presence of corneal scarring; 3. Irregular astigmatism; 4. Intraocular pressure more than 25 mm Hg; 5. Active inflammatory process of the eyeball or signs of a previous episode of inflammation; 6. Traumatic, subluxated, or complicated cataract; 7. Persistent Fetal Vasculature; 8. Diseases of the optic nerve or macula that may limit visual potential; 9. History of previous intraocular surgeries; 10. Performing posterior capsulorhexis intraoperatively.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) | measured using the Lea symbol visual acuity chart or the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart according to the patient\&amp;#39;s age |
| Uncorrected (UCNVA) and corrected (CNVA) near visual acuity | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) | measured using the Lea symbol visual acuity chart or the ETDRS chart for near according to the patient\&#39;s age |
| Refraction measurements | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) | obtained with KR-1W Wavefront Analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Keratometry measurements | recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year) | obtained with KR-1W Wavefront Analyzer |
Countries
Kazakhstan
Contacts
PRINCIPAL_INVESTIGATORKairat Ruslanuly, MD
Kazakh Eye Research Institute
Outcome results
None listed