Cataract
Conditions
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.
Interventions
PROCEDUREmodified 2.2mm microincision
enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification
PROCEDUREconventional 2.2mm microincision
conventional 2.2mm coaxial microincision phacoemulsification
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
Countries
China
Outcome results
None listed