Shanghai High Myopia Study

NCT03062085 | Recruiting DMC

• 1 other identifier: NSFC-81670835
• Study Type: observational
• Target: 60,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.

Conditions

High Myopia; Cataract; Visual Outcome; Genetic Anticipation

Outcome Measures

Primary Outcomes (3)

• Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients

  Cataract type and severity of high myopic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.

  Follow-up until five years after surgery

• Differences in the clinical phenotypes and visual outcomes of age-related cataract patients

  Cataract type and severity of age-related cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.

  Follow-up until five years after surgery

• Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients

  Cataract type and severity of ametropic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.

  Follow-up until five years after surgery

Secondary Outcomes (1)

• Genetic diversity based on biological specimen samples of three groups

  Analyzed within six months after surgery

Other Outcomes (3)

• Difference in the surgical procedure of three groups

  Recorded on the surgery day for further analysis

• Difference in the Diagnostic test of three groups

  Recorded before the surgery day for further analysis

• Difference in the complications of the cataract surgery of three groups

  Follow-up until five years after surgery

Study Arms (3)

High myopic cataract group

Cataract patients with high myopia.

Other: Cataract

Age-related cataract group

Age-related cataract patients.

Other: Cataract

Ametropic cataract group

Cataract patients with ametropia.

Other: Cataract

Interventions

Cataract OTHER

The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.

Age-related cataract group; Ametropic cataract group; High myopic cataract group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cataract patients who will undergo cataract surgery in Eye and ENT Hospital of Fudan University.

You may qualify if:

• Clinical diagnosis of cataract
• Must be able to cooperate with the ophthalmic examination

You may not qualify if:

• Clinical diagnosis of mental illness
• Mentally disabled

Sponsors & Collaborators

• Shanghai High Myopia Study Group: lead
• Eye & ENT Hospital of Fudan University: collaborator

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Related Publications (6)

• Zhang Y, Zhang S, Zhang K, Lu Y, Zhu X. Characteristics of the Corneal Endothelium in Elderly Adults with High Myopia. Phenomics. 2025 Jan 27;4(6):562-569. doi: 10.1007/s43657-024-00186-6. eCollection 2024 Dec.

  PMID: 40061825 DERIVED

• Hu X, Qi J, Cheng K, He W, Zhang K, Zhao C, Lu Y, Zhu X. Effectiveness of prophylactic capsular tension ring implantation during cataract surgery in highly myopic eyes. J Cataract Refract Surg. 2024 Oct 1;50(10):1030-1036. doi: 10.1097/j.jcrs.0000000000001495.

  PMID: 39313860 DERIVED

• He W, Wei L, Liu S, Huang Z, Qi J, Zhang K, Meng J, Du Y, Lu Y, Zhu X. Role of Optic Nerve Head Characteristics in Predicting Intraocular Pressure Spikes after Cataract Surgery in Highly Myopic Eyes. Ophthalmol Ther. 2023 Aug;12(4):2023-2033. doi: 10.1007/s40123-023-00714-z. Epub 2023 May 13.

  PMID: 37178442 DERIVED

• He W, Cheng K, Zhao L, Liu S, Huang Z, Zhang K, Du Y, Zhou X, Lu Y, Zhu X. Long-Term Outcomes of Posterior Capsular Opacification in Highly Myopic Eyes and Its Influencing Factors. Ophthalmol Ther. 2023 Aug;12(4):1881-1891. doi: 10.1007/s40123-023-00711-2. Epub 2023 May 3.

  PMID: 37138195 DERIVED

• Meng J, Chen Y, Cheng K, Qi J, Du Y, Yao Y, He W, Zhang K, Lu Y, Zhu X. LONG-TERM PROGRESSION PATTERN OF MYOPIC TRACTIONAL MACULOPATHY: Outcomes and Risk Factors. Retina. 2023 Jul 1;43(7):1189-1197. doi: 10.1097/IAE.0000000000003791.

  PMID: 36977327 DERIVED

• Lu Q, He W, Qian D, Lu Y, Zhu X. Measurement of crystalline lens tilt in high myopic eyes before cataract surgery using swept-source optical coherence tomography. Eye Vis (Lond). 2020 Mar 6;7:14. doi: 10.1186/s40662-020-00176-5. eCollection 2020.

  PMID: 32161773 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from HMC, ARC and anisometropia patients collected before the cataract surgery. Aqueous humor and capsular membranes samples from HMC, ARC and ametropic cataract patients collected during the cataract surgery.

MeSH Terms

Conditions

Cataract; Anticipation, Genetic

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Yi Lu, M.D.

  Eye and ENT Hospital of Fudan University

  STUDY CHAIR

• Xiangjia Zhu, M.D.

  Eye and ENT Hospital of Fudan University

  STUDY DIRECTOR

• Keke Zhang, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Wenwen He, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Yu Du, B.S.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Yinglei Zhang, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Zhennan Zhao, Ph.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

• Ruiqi Chang, B.S.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lu, M.D.

CONTACT

(86)021-64377134; luyieent@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (1)