Clinical trial NCT04014699: Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Official title: Clinical Evaluation of Modified 2.2mm Microincision Phacoemulsification for Age-related Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of DMD at postoperative day 1
timeFrame: postoperative day 1
Secondary outcomes:
measure: maximal incision thickness
timeFrame: postoperative day 1, day 7, month 1, month 3
measure: surgical induced-astigmatism
timeFrame: postoperative day 1, day 7, month 1, month 3
measure: the length of DMD
timeFrame: postoperative day 1, day 7, month 1, month 3
measure: Best corrected visual acuity (BCVA)
timeFrame: postoperative day 1, day 7, month 1, month 3
measure: modulation transfer function (MTF)-cut off
timeFrame: postoperative day 1, day 7, month 1, month 3
measure: central cornea endothelial cell loss
timeFrame: postoperative day 1, day 7, month 1, month 3
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dai Y, Liu Z, Wang W, Han X, Jin L, Chen X, Jin G, Wang L, Zhang E, Qu B, Liu J, Congdon N, He M, Luo L, Liu Y. Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Nov 1;139(11):1228-1234. doi: 10.1001/jamaophthalmol.2021.4148.