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Clinical Trials/RBR-56xh4c
RBR-56xh4c
Not yet recruiting
未知

Efficiency and efficacy study of a new family of monofocal and multifocal intraocular lenses in the Cataract Personalized Solution Project.

Hospital Evangélico de Belo Horizonte0 sitesAugust 27, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Hospital Evangélico de Belo Horizonte
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 27, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Intervention

Investigators

Sponsor
Hospital Evangélico de Belo Horizonte

Eligibility Criteria

Inclusion Criteria

  • Patients who had a clinically documented diagnosis of age\-related cataract (cortical, nuclear, sub\-capsular or a combination) that was considered amenable to cataract extraction by the intracapsular facectomy method.
  • Adult patients 21 years of age or older.
  • Patients eligible for primary intraocular lens implantation.
  • Patients willing and able to perform clinical and follow\-up examinations for a minimum of 1 year after cataract surgery.
  • Patients requiring intraocular lens implantation powers ranging from 10 to 30 diopters.
  • Patients with a visual potential of 20/40 or better in the eye indicated for intraocular lens implantation.
  • Patients with a corneal cylinder corrected for less than 1 diopter.

Exclusion Criteria

  • Patients with any pathology of the anterior segment in which the intracapsular facectomy procedure with primary IOL implant is contraindicated (examples: keratoconus, dystrophy or corneal scars, anterior uveitis).
  • Patients with corneal inflammation or edema, including but not limited to: keratitis, keratoconjunctivitis and ceratouveitis.
  • Patients with uncontrolled glaucoma or glaucoma under treatment.
  • Patients with history of retinal detachment.
  • Patients with diabetic retinopathy (proliferative or non\-proliferative).
  • Patients with congenital, metabolic, traumatic or complicated cataract.
  • Patients with marked microphthalmia or aniridia.
  • Patients who had previous ocular surgery of the proposed eye.
  • Patients who have already received other IOLs in the contralateral eye.
  • Irregular corneal astigmatism.

Outcomes

Primary Outcomes

Not specified

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