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Completed

NCT Number: NCT04014699

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

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

modified 2.2mm microincision

Procedure

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

conventional 2.2mm microincision

Procedure

conventional 2.2mm coaxial microincision phacoemulsification

Primary outcomes

  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 outcomes

  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. central cornea endothelial cell loss

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 10, 2019
Registry last updated
Sep 16, 2020

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.

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