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Intraocular Lens Implantation Surgery vs Traditional Cataract Surgery

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ClinicalTrials.gov Identifier: NCT03240796
Recruitment Status : Not yet recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 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: intraocular lens implantation Procedure: traditional cataract surgery Not Applicable

Detailed Description:
A Prospective,randomized controlled study of eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: the participants had a intraocular lens implantation, 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 after the first and the second surgery, aiming at comparison of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Intraocular Lens Implantation Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: traditional cataract surgery Procedure: 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: intraocular lens implantation surgery Procedure: 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: 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.




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.


Secondary Outcome Measures :
  1. Change from Baseline in central posterior capsule thickness [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 ]
    Central posterior capsule thickness was recorded and calculated by Pentacam HR system

  2. Change from Baseline in central posterior capsule density [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 ]
    Central posterior capsule density was recorded and calculated by Pentacam HR system.

  3. Change from Baseline in best corrected visual acuity [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3, post-operative month 6, post-operative year 1 ]
    Best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist.

  4. Change from Baseline in posterior capsule opacification grading score [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3 ]
    osterior capsule opacification(PCO)was recorded by standardized slit lamp retroillumination images and analyzed using the EPCO2000 program. The severity of PCO was clinically graded from 0 (none) to 4 (severe)

  5. The refraction status (presented as spherical equivalent, SE) [ Time Frame: post-operative day 1, post-operative week 1, post-operative month 1, post-operative month 3 ]
    Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.



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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): NCT03240796


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: NCT03240796     History of Changes
Other Study ID Numbers: CCPMOH2017-China-4
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

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
intraocular lens implantation
traditional cataract surgery

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases