Visual Function in Pediatric Patients With Posterior Lens Opacities

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT05207007
Collaborator
(none)
63
1
19.8
3.2

Study Details

Study Description

Brief Summary

Prognostic factors determining visual outcomes in patients with posterior polar cataracts and posterior lenticonus are largely unknown. In this trial, the investigators aimed to evaluate the visual outcomes in patients with posterior polar cataracts and posterior lenticonus and try to find out the factors associated with the visual acuity after surgery. Patients enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation

Detailed Description

Congenital cataract patients have a wide range of presentations of lens opacities with different impact on visual function. Polar cataracts are opacities of the subcapsular cortex in the polar regions of the lens. To our knowledge, anterior polar cataracts are usually visually insignificant, however, even a small posterior lens opacity can impair vision because of their close proximity to the macula. Visual impairment could be caused by an opacity that blocks the visual axis, refractive error, posterior lesion-induced optical distortion, or amblyopia. Therefore, surgery is often recommended when visual function is significantly affected. The primary indication for surgical intervention in cataract is poor visual acuity. However, the previous studies have shown that preoperative visual acuity is a poor predictor of improvement in the subjectively experienced quality of vision after cataract surgery. Considering the increased risk for capsule rupture during surgery and the sacrifice of accommodation after cataract surgery in eyes with posterior lens opacities, the decision of surgical intervention must be carefully weighed.

In this trial, the investigators aimed to evaluate the changes of visual function, including visual acuity, modulation transfer function, ocular aberrations in the participants with posterior lens opacities. Moreover, various factors which might be associated with postoperative visual acuity were explored. The participants enrolled in this study will be followed for at least 6 months and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month postoperatively.

Study Design

Study Type:
Observational
Actual Enrollment :
63 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Visual Function in Pediatric Patients With Posterior Polar Cataracts and Posterior Lenticonus
Actual Study Start Date :
Jan 4, 2020
Actual Primary Completion Date :
Aug 29, 2021
Actual Study Completion Date :
Aug 29, 2021

Arms and Interventions

Arm Intervention/Treatment
posterior polar cataracts

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients. Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation
Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

posterior lenticonus

Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation were performed in these patients. Drug: Subconjunctival dexamethasone and general anesthesia All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.

Procedure: Phacomulsification lens removal cataract surgery with Intraocular lens(IOL) implantation
Phacomulsification lens removal cataract surgery with IOL implantation in both two groups

Outcome Measures

Primary Outcome Measures

  1. Visual acuity (BCVA) [6 month after surgery]

    Visual acuity (BCVA) measured by ETDRS chart after surgery

  2. Stereoacuity [6 month after surgery]

    Stereoacuity measured at 40 cm using the Randot stereotests

  3. modulation transfer function (MTF) [6 month after surgery]

    MTF measured with the Optical Quality Analysis System

  4. monochromatic aberrations [6 month after surgery]

    monochromatic aberrations measured by the iTrace Dynamic Laser Refraction

Secondary Outcome Measures

  1. Location of the cataracts [before surgery]

    divided into central, paracentral, and peripheral

  2. size of lens lesion [before surgery]

    measured by image J

  3. Visual acuity (BCVA) [before surgery]

    Visual acuity (BCVA) measured by ETDRS chart before surgery

  4. Stereoacuity [before surgery]

    Stereoacuity measured at 40 cm using the Randot stereotests

  5. modulation transfer function (MTF) [before surgery]

    MTF measured with the Optical Quality Analysis System

  6. monochromatic aberrations [before surgery]

    monochromatic aberrations measured by the iTrace Dynamic Laser Refraction system

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 14 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Children with posterior polar cataracts or posterior lenticonus who need cataract surgery

  • Aged 3-14 years

  • Have signed a consent form

  • Can be followed

Exclusion Criteria:
  • Have relevant ocular disease other than congenital cataract

  • Could not cooperate to the examinations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou China

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Weirong Chen, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haotian Lin, Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05207007
Other Study ID Numbers:
  • CCPMOH2020-China20
First Posted:
Jan 25, 2022
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Haotian Lin, Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2022