Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05654025
Collaborator
(none)
600
1
59.9
10

Study Details

Study Description

Brief Summary

This is a single-centre, observational cohort study with the following objectives: Firstly, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients. Secondly, the investigators target to investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis. Thirdly, to explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis. Lastly, this study aims to explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Congenital ectopia lens is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, the changes in vision-related quality of life, mental health status, ocular biological parameters postoperative congenital dislocation of lens have not been systematically studied in the Chinese population.

    In this trial, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients, investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis, explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis, and explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens
    Actual Study Start Date :
    Dec 5, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2027
    Anticipated Study Completion Date :
    Dec 1, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Non-surgical group: Refractive change, ocular parameter changes, and prognosis without surgery

    To evaluate the long-term changes in refractive state, ocular parameter, ocular development and visual prognosis in patients without congenital ectopia lentis surgery.

    Surgical group: Safety and efficacy of different congenital ectopia lentis surgeries

    To compare the safety and efficacy of different congenital ectopia lentis surgeries, including phacoemulsification, phacoemulsification + Intraocular lens (IOL) implantation, phacoemulsification + IOL implantation + Capsular Tension Ring implantation or phacoemulsification + IOL implantation + transscleral fixation.

    Outcome Measures

    Primary Outcome Measures

    1. Change of best corrected visual acuity [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3, 6 months, and 1, 2, 3 years postoperation]

      Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each visit.

    2. Incidence of complications [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3, 6 months, and 1, 2, 3 years postoperation.]

      Estimate the incidence of complications for both non-surgical group and surgical group.

    Secondary Outcome Measures

    1. Change of axial length [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3, 6 months, and 1, 2, 3 years postoperation.]

      Axial length will be evaluated with ZEISS IOLMaster 700 at each visit.

    2. High order aberrations [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3, 6 months, and 1, 2, 3 years postoperation]

      High order aberrations will be assessed with Nidek OPD-Scan III at each visit.

    3. Central cornea endothelial cell loss [Preoperation, and 3, 6 months, and 1, 2, 3 years postoperation]

      Central cornea endothelial cell loss will be calculated with endokeratoscope in surgical group.

    4. The state of zonules [Non-surgical group is assessed at first visit, and 1, 2, 3 years after enrollment. Surgical group will be assessed preoperation.]

      The state of zonules will be assessed using ultrasound biomicroscopy.

    5. Anterior chamber angle. [Non-surgical group is assessed at first visit, and 1, 2, 3 years after enrollment. Surgical group will be assessed preoperation, 3, 6 months, and 1, 2, 3 years postoperation.]

      Anterior chamber angle will be assessed using Tomey Casia 2 anterior segment optical coherence tomography (OCT).

    6. Tilt and eccentricity of intraocular lens [3, 6 months, and 1, 2, 3 years postoperation]

      Tilt and eccentricity of intraocular lens was evaluated with Pentacam in surgical group.

    7. Intraocular pressure [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3, 6 months, and 1, 2, 3 years postoperation.]

      Intraocular pressure with non-contact-tonometer at each visit.

    8. Aortic root diameter [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation]

      Aortic root diameter will be measured using echocardiography.

    9. Aortic Root (Sinuses of Valsalva) Z-score, adjusted by body-surface-area (Z-score) [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation]

      Z-Score will be calculated using the Marfan foundation's calculator (https://marfan.org/dx/zscore-children/). Normal Z-score range from -2 to 2. A dilated aortic root is defined as a Z-score ≥2.0. A larger Z-score is associated with an increased risk of aortic complications such as dissection, rupture, and valvular regurgitation.

    10. Incidence of valvular heart disease [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation]

      The incidence of valvular heart disease (VHD) is defined as the ratio of patients diagnosed with VHD to the total number of patients enrolled.

    11. Body mass index (BMI) [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.]

      Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. The normal range for the Chinese population is 18.5 to 23.9. A high BMI can indicate high body fatness.

    12. Metacarpophalangeal joint length [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.]

      Metacarpophalangeal joint length will be measured using palmar radiograph.

    13. Choroidal thickness [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.]

      Choroidal thickness will be measured with optical coherence tomography (OCT) images.

    14. Choriocapillaris flow deficits [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.]

      Choriocapillaris flow deficits will be measured with optical coherence tomography angiography (OCTA) images.

    15. Genetic mutation state of patients [Preoperation]

      Draw blood to detect the exact gene mutations in patients via whole-exome sequencing.

    16. Vision-related quality of life [Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.]

      Vision-related quality of life will be assessed with the Pediatric Eye Questionnaire (PedEyeQ).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Clinical diagnosis of Congenital Ectopia Lentis.

    • Able to cooperate in the examinations.

    Exclusion Criteria:
    • History of ophthalmic trauma or other ophthalmic surgeries.

    • Other ophthalmic diseases such as glaucoma, uveitis and corneal disease.

    • Uncooperate in the examinations.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    • Principal Investigator: Danying Zheng, Guangdong Provincial Clinical Research Center for Ocular Diseases

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05654025
    Other Study ID Numbers:
    • 2022KYPJ207
    First Posted:
    Dec 16, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 27, 2022