Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060, China
NCT Number: NCT04014699
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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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Guangzhou, 510060, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification
conventional 2.2mm coaxial microincision phacoemulsification
Time frame: postoperative day 1
Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1
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
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
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
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
Time frame: postoperative day 1, day 7, month 1, month 3
modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit
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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
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