Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts

NCT06966167 | Recruiting

• 1 other identifier: Fuchs FLACS vs CPS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the mid- to long-term efficacy of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) in patients with moderate to severe Fuchs' endothelial corneal dystrophy (FECD) complicated by cataracts. The main questions it aims to answer are: Does FLACS lead to better preservation of corneal endothelial cells compared to CPS in patients with moderate to severe FECD? How do visual outcomes and corneal transparency compare between FLACS and CPS in this patient population? Comparison Group: Researchers will compare patients undergoing FLACS with those undergoing CPS to evaluate differences in endothelial cell loss, corneal thickness, visual acuity, and corneal transparency. Participants: Adults aged 40 years and older diagnosed with moderate to severe FECD (endothelial cell density \<1500 cells/mm²). Patients scheduled for cataract surgery at participating centers. Participants will undergo: Preoperative evaluations, including visual acuity tests, corneal endothelial cell density assessment (central and five peripheral zones), corneal thickness, and corneal densitometry. Surgical intervention with either FLACS or CPS. Postoperative follow-ups at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, including assessments of endothelial cell density, visual acuity, and corneal thickness. This study aims to provide evidence-based recommendations for optimizing surgical strategies in high-risk patients with FECD and cataracts.

Conditions

Fuchs Endothelial Corneal Dystrophy; Cataract

Keywords

Fuchs Endothelial Corneal Dystrophy; Cataract; Femtosecond Laser-Assisted Cataract Surgery; Conventional Phacoemulsification Surgery

Outcome Measures

Primary Outcomes (2)

• Change in central corneal endothelial cell density (ECD) from baseline to postoperative time points

  From enrollment to the end of treatment at 2years

• Change in corneal thickness from baseline to postoperative time points

  From enrollment to the end of treatment at 2years

Secondary Outcomes (2)

• Change in corneal densitometry (central, superior, inferior, nasal, temporal zones)

  From enrollment to the end of treatment at 2years

• Postoperative visual acuity outcomes (UDVA, CDVA)

  From enrollment to the end of treatment at 2years

Study Arms (2)

conventional phacoemulsification surgery (CPS)

femtosecond laser-assisted cataract surgery (FLACS)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 40 years or older, diagnosed with moderate to severe Fuchs endothelial corneal dystrophy (endothelial cell density \< 1500 cells/mm²), and presenting with visually significant cataract.

You may qualify if:

• Patients scheduled for cataract surgery
• Age ≥40 years
• Diagnosed with moderate to severe FECD (endothelial cell density \<1500 cells/mm²)

You may not qualify if:

• History of prior intraocular surgery
• Presence of ocular conditions other than FECD and cataracts (e.g., severe dry eye, corneal scarring, keratoconus, uveitis, uncontrolled glaucoma, vitreoretinal disease)
• Requirement for additional intraocular procedures during the study period (excluding Nd:YAG posterior capsulotomy)

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (4)

• Lupardi E, Moramarco A, Cassini F, Febbraro S, Savini G, Fontana L. Corneal densitometry measurements comparison between anterior segment OCT and scheimpflug imaging. Int Ophthalmol. 2024 Sep 25;44(1):392. doi: 10.1007/s10792-024-03309-0.

  PMID: 39320570 BACKGROUND

• Aiello F, Gallo Afflitto G, Ceccarelli F, Cesareo M, Nucci C. Global Prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) in Adult Population: A Systematic Review and Meta-Analysis. J Ophthalmol. 2022 Apr 14;2022:3091695. doi: 10.1155/2022/3091695. eCollection 2022.

  PMID: 35462618 BACKGROUND

• Ali M, Cho K, Srikumaran D. Fuchs Dystrophy and Cataract: Diagnosis, Evaluation and Treatment. Ophthalmol Ther. 2023 Apr;12(2):691-704. doi: 10.1007/s40123-022-00637-1. Epub 2023 Jan 13.

  PMID: 36637659 BACKGROUND

• Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.

  PMID: 9071233 BACKGROUND

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Central Study Contacts

Jin Yang

CONTACT

+86 021-64377134; jin_er76@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 11, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

CN (1)