Skip to main content
OpenTrials
Completed

NCT Number: NCT04839250

Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery

To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

About this study

To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnose age-related cataract;
  • Plan to perform phacoemulsification of cataract with intraocular lens implantation;
  • Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
  • Able to understand and independently fill in the informed consent form and postoperative follow-up plan.

Exclusion criteria

  • Cataract caused by other reasons;
  • Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
  • Corneal diseases, corneal endothelial cells <1800/mm2;
  • Small palpebral fissure;
  • Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
  • Those who cannot cooperate with the inspection and have not completed the one-month follow-up

Treatment and study plan

heads-up method

Procedure

3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.

Primary outcomes

  1. change of corneal incision from 1day after surgery to 1 months

    Time frame: up to 1day,1week,1 month

    the shape and length of the corneal incision ,if descemet's layer detachment happens

  2. corneal endothelial cell density

    Time frame: up to 1 month

    the number of corneal endothelial cells per unit area

Secondary outcomes

  1. best corrected visual acuity

    Time frame: up to 1 month

    best corrected visual acuity

  2. change from baseline central corneal thickness at 1 months

    Time frame: up to 1 day,1 week,1 month

    thickness in micrometer

  3. change from baseline corneal incision thickness at 1 months

    Time frame: up to 1 day,1 week,1 month

    Thickness of corneal incision

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2021
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.