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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: conventional 2.2mm microincision; Procedure: modified 2.2mm microincision

• Registration Number: NCT04014699
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-07-06
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Study Start: 2019-07-22
• Primary Completion: 2019-10-22
• Study Completion: 2020-01-22
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional 2.2mm microincision	conventional 2.2mm microincision	-
modified 2.2mm micoincision	modified 2.2mm microincision	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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
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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, China