Trials Sponsors Conditions Drugs Pricing

Conditions

Astigmatism Cataract Congenital IOL

Keywords

Cataract CongenitalAstigmatismToric IOL

Outcome Measures

Primary Outcomes (3)

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\&amp;#39;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\&#39;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)

Secondary Outcomes (1)

Keratometry measurements
recorded at each follow-up (on the fifth day, first month, third month, sixth month, and first year)

Study Arms (2)

Toric

EXPERIMENTAL

A folding hydrophobic acrylic IOLs AcrySof IQ Toric SN6ATx and Clareon Toric CNW0Tx

Procedure: congenital/pediatric cataract surgeryDevice: Toric IOLs

Non-toric

ACTIVE COMPARATOR

A folding hydrophobic acrylic intraocular lens (IOL) AcrySof IQ SN60WF and Clareon SY60WF

Procedure: congenital/pediatric cataract surgeryDevice: Non-Toric IOLs

Interventions

congenital/pediatric cataract surgeryProcedure

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.

Also known as: phacoaspiration

Non-toricToric

Eligibility Criteria

Age6 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Visually significant cataract;
Corneal astigmatism more than 1.25 diopters;

Sponsors & Collaborators

Kazakh Eye Research Institute
Research networklead

Study Sites (2)

Kazakh Eye Research Institute

Almaty, 050012, Kazakhstan

Kazakh Eye Research Institute

Astana, 010000, Kazakhstan

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

Kairat Ruslanuly, MD
Kazakh Eye Research Institute
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: NETWORK
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: a researcher, a vitreoretinal surgeon

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

March 1, 2024

Actual (reported)

Toric Intraocular Lens Implantation in Pediatric Cataract

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (2)

Toric

Non-toric

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (2)

Toric

Non-toric

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations