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

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ClinicalTrials.gov Identifier: NCT04014699
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongshan Ophthalmic Center, Sun Yat-sen University

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 disease Intervention/treatment Phase
Cataract Procedure: modified 2.2mm microincision Procedure: conventional 2.2mm microincision Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 22, 2019
Estimated Primary Completion Date : October 22, 2019
Estimated Study Completion Date : January 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/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




Primary Outcome Measures :
  1. Incidence of DMD at postoperative day 1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: postoperative day 1, day 7, month 1, month 3 ]
    modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit

  6. incidence of DMD at postoperative day 7, month 1, month 3 [ Time Frame: postoperative day 7, month 1, month 3 ]
    Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 7, month 1, month 3



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014699


Contacts
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Contact: Ye Dai, PhD 8613512721192 13512721192@163.com
Contact: Xiaozhang Qiu, Bachelor 8613751871820 625215149@qq.com

Locations
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China
Zhongshan Ophthalmic Center, Sun Yat-sen University Not yet recruiting
Guangzhou, China, 510060
Contact: Ye Dai, PhD    8613512721192    13512721192@163.com   
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
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Principal Investigator: Yizhi Liu, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04014699     History of Changes
Other Study ID Numbers: 2019KYPJ091
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases