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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014699
• Other study ID #: 2019KYPJ091
• Status: Completed
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: January 22, 2020

Study information

• Verified date: September 2020
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 22, 2020
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DMD at postoperative day 1	Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1	postoperative day 1
Secondary	maximal incision thickness	maximal incision thickness measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3	postoperative day 1, day 7, month 1, month 3
Secondary	surgical induced-astigmatism	surgical induced-astigmatism was calculated at each postoperative visit using the following equation: K2 = [K1 2 + K32 -2 K1 K3 cos (2?3 -2?1)]1/2	postoperative day 1, day 7, month 1, month 3
Secondary	the length of DMD	the length of incision-site descemet membrane detachment measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3	postoperative day 1, day 7, month 1, month 3
Secondary	Best corrected visual acuity (BCVA)	Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each postoperative visit	postoperative day 1, day 7, month 1, month 3
Secondary	modulation transfer function (MTF)-cut off	modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit	postoperative day 1, day 7, month 1, month 3
Secondary	central cornea endothelial cell loss	Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.	postoperative day 1, day 7, month 1, month 3