Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04014699
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
21.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: modified 2.2mm microincision
  • Procedure: conventional 2.2mm microincision
N/A

Detailed Description

2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.

The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore,the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.

In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Actual Study Start Date :
Jul 22, 2019
Actual Primary Completion Date :
Oct 22, 2019
Actual Study Completion Date :
Jan 22, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: modified 2.2mm micoincision

Procedure: modified 2.2mm microincision
enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification

Active Comparator: conventional 2.2mm microincision

Procedure: conventional 2.2mm microincision
conventional 2.2mm coaxial microincision phacoemulsification

Outcome Measures

Primary Outcome Measures

  1. Incidence of DMD at postoperative day 1 [postoperative day 1]

    Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1

Secondary Outcome Measures

  1. maximal incision thickness [postoperative day 1, day 7, month 1, month 3]

    maximal incision thickness measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3

  2. surgical induced-astigmatism [postoperative day 1, day 7, month 1, month 3]

    surgical induced-astigmatism was calculated at each postoperative visit using the following equation: K2 = [K1 2 + K32 -2 K1 K3 cos (2θ3 -2θ1)]1/2

  3. the length of DMD [postoperative day 1, day 7, month 1, month 3]

    the length of incision-site descemet membrane detachment measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3

  4. Best corrected visual acuity (BCVA) [postoperative day 1, day 7, month 1, month 3]

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

  5. modulation transfer function (MTF)-cut off [postoperative day 1, day 7, month 1, month 3]

    modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit

  6. central cornea endothelial cell loss [postoperative day 1, day 7, month 1, month 3]

    Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Aged-related cataract patients between 65 and 90 years ;

  • Lens nuclear opalescence grade ≥4.0 on the Lens Opacities Classification System III (LOCS III);

  • Scheduled for phacoemulsification combined with intraocular lens implantation.

  • The number of corneal endothelial cells > 1500cells/mm2.

  • Dilated pupil diameter ≥6mm

Exclusion Criteria:
  • A history of ophthalmic trauma or surgery;

  • Other ophthalmic diseases such as glaucoma, uveitis, high myopia;

  • Ocular factors that would make surgery challenging or dangerous, including but not limited to small pupil, shallow anterior chamber, etc.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Zhongshan Ophthalmic Center, Sun Yat-sen UniversityGuangzhouChina510060

Sponsors and Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhi Liu, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04014699
Other Study ID Numbers:
  • 2019KYPJ091
First Posted:
Jul 10, 2019
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020