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

NCT ID: NCT05654025

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

604 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-05

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ectopia Lentis Dislocation, Lens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with congenital lens dislocation and age ≥ 3 years old.
* Agree to participate in this study with written informed consent from patients or legal guardians.

Exclusion Criteria

* History of ophthalmic trauma or other ophthalmic surgeries.
* Combined with other ophthalmic diseases such as primary glaucoma, uveitis and corneal disease.
* Patients who could not cooperate in the examinations.
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danying Zheng

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Clinical Research Center for Ocular Diseases

Locations

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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

Site Status RECRUITING

Countries

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China

Central Contacts

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Dangying Zheng, M.D

Role: CONTACT

020-87330478

Facility Contacts

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Yizhi Liu, PhD

Role: primary

References

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Kaur K, Gurnani B. Ectopia Lentis. 2023 Jun 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK578193/

Reference Type RESULT
PMID: 35201721 (View on PubMed)

Lin J, Gong N, Cao Q, Zhou Y, Cai Y, Jin G, Young CA, Yang J, Wang Y, Zheng D. What hinders congenital ectopia lentis patients' follow-up visits? A qualitative study. BMJ Open. 2020 Mar 12;10(3):e030434. doi: 10.1136/bmjopen-2019-030434.

Reference Type RESULT
PMID: 32169922 (View on PubMed)

Guo D, Jin G, Zhou Y, Zhang X, Cao Q, Lian Z, Guo Y, Zheng D. Mutation spectrum and genotype-phenotype correlations in Chinese congenital ectopia lentis patients. Exp Eye Res. 2021 Jun;207:108570. doi: 10.1016/j.exer.2021.108570. Epub 2021 Apr 16.

Reference Type RESULT
PMID: 33844962 (View on PubMed)

Minsel WR, Bommert H, Pieritz R. [Relationship between speech--formal psychotherapeutic signs and results of client-centered discussion psychotherapy]. Z Klin Psychol Psychother. 1972;20(4):303-10. No abstract available. German.

Reference Type RESULT
PMID: 4662920 (View on PubMed)

Jin GM, Fan M, Cao QZ, Lin JX, Zhang YC, Lin JQ, Wang YY, Young CA, Zheng DY. Trends and characteristics of congenital ectopia lentis in China. Int J Ophthalmol. 2018 Sep 18;11(9):1545-1549. doi: 10.18240/ijo.2018.09.19. eCollection 2018.

Reference Type RESULT
PMID: 30225232 (View on PubMed)

Meng X, Cao X, Jia Y, Pan J, Du Y, Li X. Sutured Scleral Fixation of Posterior Chamber Intraocular Lens in Children under the Age of 9 with Congenital Ectopia Lentis. Ophthalmic Res. 2021;64(5):837-843. doi: 10.1159/000516324. Epub 2021 Jul 9.

Reference Type RESULT
PMID: 34247162 (View on PubMed)

Chen T, Chen J, Jin G, Zhang M, Chen Z, Zheng D, Jiang Y. Clinical Ocular Diagnostic Model of Marfan Syndrome in Patients With Congenital Ectopia Lentis by Pentacam AXL System. Transl Vis Sci Technol. 2021 Jun 1;10(7):3. doi: 10.1167/tvst.10.7.3.

Reference Type RESULT
PMID: 34061947 (View on PubMed)

Chen Z, Chen T, Zhang M, Chen J, Deng M, Zheng J, Lan LN, Jiang Y. Fibrillin-1 gene mutations in a Chinese cohort with congenital ectopia lentis: spectrum and genotype-phenotype analysis. Br J Ophthalmol. 2022 Dec;106(12):1655-1661. doi: 10.1136/bjophthalmol-2021-319084. Epub 2021 Jul 19.

Reference Type RESULT
PMID: 34281902 (View on PubMed)

Fuchs J, Rosenberg T. Congenital ectopia lentis. A Danish national survey. Acta Ophthalmol Scand. 1998 Feb;76(1):20-6. doi: 10.1034/j.1600-0420.1998.760105.x.

Reference Type RESULT
PMID: 9541430 (View on PubMed)

Zhang Y, Jin G, Young CA, Cao Q, Lin J, Lin J, Wang Y, Zheng D. Analysis of Corneal Astigmatism before Surgery in Chinese Congenital Ectopia Lentis Patients. Curr Eye Res. 2018 Aug;43(8):972-976. doi: 10.1080/02713683.2018.1470248. Epub 2018 May 23.

Reference Type RESULT
PMID: 29698085 (View on PubMed)

Liu L, Li X, Cao Q, Lian Z, Wu J, Jin G, Zheng D. A Modified Knotless Transscleral Intraocular Lens Fixation Technology for Congenital Ectopia Lentis. Ophthalmol Ther. 2023 Feb;12(1):99-110. doi: 10.1007/s40123-022-00586-9. Epub 2022 Oct 15.

Reference Type RESULT
PMID: 36243894 (View on PubMed)

Chen H, Ng KY, Li S, Jin G, Cao Q, Lian Z, Luo X, Ding X, Zheng D. CHARACTERISTICS OF THE FOVEAL MICROVASCULATURE IN CHILDREN WITH MARFAN SYNDROME: An Optical Coherence Tomography Angiography Study. Retina. 2022 Jan 1;42(1):138-151. doi: 10.1097/IAE.0000000000003272.

Reference Type RESULT
PMID: 34935768 (View on PubMed)

Xu P, Ng K, Jin L, Young CA, Liu S, Liang X, Liu Z, Zhang X, Jin G, Zheng D. Visual prognosis and complications of congenital ectopia lentis: study protocol for a hospital-based cohort in Zhongshan Ophthalmic Center. BMJ Open. 2023 Jun 27;13(6):e072542. doi: 10.1136/bmjopen-2023-072542.

Reference Type DERIVED
PMID: 37369426 (View on PubMed)

Other Identifiers

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2022KYPJ207

Identifier Type: -

Identifier Source: org_study_id

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