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Trial record 32 of 39 for:    Recruiting, Not yet recruiting, Available Studies | "Lenses, Intraocular"

Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

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ClinicalTrials.gov Identifier: NCT03230799
Recruitment Status : Not yet recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
In this study, the investigators give participants who had a lens implantation before a secondary intraocular lens implantation in the purpose of reduce complications of surgeries for dense cataract , and report a prospective, non-randomized controlled study aiming at comparison of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts

Condition or disease Intervention/treatment Phase
Cataract Procedure: secondary intraocular lens implantation Procedure: minimal invasive lens surgery Procedure: traditional cataract surgery Not Applicable

Detailed Description:
A Prospective, non-randomized controlled study of eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: the participants had a minimal invasive lens surgery, while in Group II, the participants had a traditional cataract surgery. Investigators give two groups a secondary intraocular lens implantation. Investigators compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, aiming at comparison of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: traditional cataract surgery Procedure: secondary intraocular lens implantation
before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.

Procedure: traditional cataract surgery
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy

Experimental: minimal invasive lens surgery Procedure: secondary intraocular lens implantation
before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.

Procedure: minimal invasive lens surgery
before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.




Primary Outcome Measures :
  1. The refraction status (presented as spherical equivalent, SE) [ Time Frame: baseline ]
    Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.

  2. Demography (age, sex, and laterality) [ Time Frame: baseline ]
    The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.



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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 1 month and 24 months
  • Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
  • Informed consent signed by a parent or legal guardian

Exclusion Criteria:

  • Intraocular pressure >21 mmHg
  • Preterm birth (<28 weeks)
  • Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
  • History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
  • History of ocular trauma
  • Microcornea
  • Persistent hyperplastic primary vitreous
  • Rubella
  • Lowe syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230799


Contacts
Contact: Jing Li, M.D +86-20-87330341 Reviewborad_SYsU@163.com

Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Haotian Lin, M.D,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03230799     History of Changes
Other Study ID Numbers: CCPMOH2017-China-3
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haotian Lin, Sun Yat-sen University:
dense cataract
lens-shell technique
secondary intraocular lens implantation

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases