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

NCT05654025 | Recruiting

• 1 other identifier: 2022KYPJ207
• Study Type: observational
• Target: 604
• Locations: 1 country
• Sites: 1

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.

Conditions

Ectopia Lentis; Dislocation, Lens

Outcome Measures

Primary Outcomes (2)

• Change of best corrected visual acuity

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

  Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation

• Incidence of complications

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

  Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation.

Secondary Outcomes (16)

• 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 months, and 1, 2, 3 years postoperation.

• 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 months, and 1, 2, 3 years postoperation

• Central cornea endothelial cell loss

  Preoperation, and 3 months, and 1, 2, 3 years postoperation

• 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.

• 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 months, and 1, 2, 3 years postoperation.

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with congenital ectopia lentis at Zhongshan ophthalmic center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (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, 510060, China

RECRUITING

Related Publications (13)

• 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/

  PMID: 35201721 RESULT

• 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.

  PMID: 32169922 RESULT

• 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.

  PMID: 33844962 RESULT

• 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.

  PMID: 4662920 RESULT

• 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.

  PMID: 30225232 RESULT

• 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.

  PMID: 34247162 RESULT

• 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.

  PMID: 34061947 RESULT

• 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.

  PMID: 34281902 RESULT

• 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.

  PMID: 9541430 RESULT

• 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.

  PMID: 29698085 RESULT

• 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.

  PMID: 36243894 RESULT

• 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.

  PMID: 34935768 RESULT

• 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.

  PMID: 37369426 DERIVED

MeSH Terms

Conditions

Ectopia Lentis; Lens Subluxation

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Lens Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Danying Zheng

  Guangdong Provincial Clinical Research Center for Ocular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dangying Zheng, M.D

CONTACT

020-87330478; zhengdyy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 16, 2022
• Study Start: December 5, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available on December 2027 for 10 years.
• Access Criteria: Data are available upon reasonable request by contacting with the corresponding author.

Locations

CN (1)