Traumatic Cataract Clinical Trial
Official title:
Early Vs Late Post Traumatic Cataract Surgery and Intraocular Lens Implantation
In a randomized clinical trial, 30 eyes with traumatic cataract after open globe injury with IOL implantation underwent early and 30 eyes underwent late cataract surgery. We excluded patients who were under 12-year-old. All patients were visited at 1week, 4 weeks , 12 weeks and six months after surgery. In each visit, patients were examined regarding visual acuity, intraocular pressure (IOP), anterior chamber inflammation, IOL position and posterior synechiae. In addition, posterior segment evaluation and funduscopy were performed. Intraoperative complication including posterior capsular rupture, anterior vitrectomy and zonulysis as well as the site of IOL implantation were documented and postoperative complications including raised IOP, anterior chamber inflammation, visual axis opacity, posterior synechiae, subluxation of IOL, IOL pigment deposition were listed.
In a randomized clinical trial, 30 eyes with traumatic cataract after open globe injury
underwent early (during the first week after the trauma) (Group 1) and 30 eyes underwent
late cataract surgery (after one month of the trauma) (Group 2) (Figure 1a). All cases were
observed for at least a 6-month period after the surgery.
Inclusion criteria included patients older than 12-year-old with significant traumatic
cataract after open globe injury. Exclusion criteria included patients with anterior capsule
rupture as well as disseminated lens materials in the anterior chamber (Figure 1b), patients
with hypopyon, eyes undergoing simultaneous primary repair and cataract extraction, cases
that IOL implantation was not possible and patients with direct trauma to the posterior
segment or with lacerations associated with vitreous prolapse.
In those cases, that IOL power calculation was not possible by the biometry of the affected
eye, it was performed using the biometry of the fellow eye. The Ethics Committee of Tehran
University of Medical Sciences approved the conduction of the present study and all
procedures started after written informed consent was obtained following the explaining the
possible consequences of the different methods of treatment to patients. All procedures were
performed by the same surgeon (M.B.R.).
All cases underwent lensectomy using vitrectomy probe through the limbal incision. We
excluded those patients who needed pars plana vitrectomy from the study. Anterior
capsulectomy was performed using a vitrectomy probe and anterior vitrectomy was performed in
cases of posterior capsular rupture or vitreous prolapse because of zonular dehiscence. If
there was a too hard nuclear part for the vitrectomy probe, we emulsified and suctioned the
nucleus using a phacoemulsification handpiece. If the capsular integrity permitted, a
posterior chamber IOL was implanted. In this situation, if posterior capsule was not intact,
a three piece acrylic foldable (Alcon MA60) IOL was implanted. In other situations, a
one-piece foldable acrylic (Alcon SA60) IOL was implanted.
Patients were randomly assigned for early or late cataract extraction and IOL implantation.
Randomization was based on a computer-generated sequence based on permuted block
randomization method. The length of blocks varied randomly between two, four and six
patients. A biostatistician performed the randomization and the sequence of randomization
was concealed from the investigators.
All patients received prophylactic oral antibiotic therapy (ciprofloxacin 750 mg twice daily
for three days) following the open globe injury. (1). Following surgery, topical
antibiotics, corticosteroids and cycloplegics were prescribed and then topical steroids were
continued for four weeks and tapered gradually during this period.
We visited all patients at 1week, 4weeks and 12 weeks and 6 months after surgery. In each
visit, patients were examined regarding visual acuity, intraocular pressure (IOP), anterior
chamber inflammation, IOL position and posterior synechiae. In addition, posterior segment
evaluation and funduscopy were performed. Anterior chamber inflammation assessed by
Standardization of Uveitis Nomenclature (SUN) Working Group grading scheme for anterior
chamber cells and flare and grade ≥2+ was considered significant (14). BCVA ( best corrected
contact lens visual acuity) of both eyes was evaluated in logMAR at six months of follow up
visits. Another surgeon who did not know timing of the surgery (M.S.) performed this
evaluation.
Sample size was calculated as 30 eyes to have a power of 90% to detect a difference of 0.2
logMAR in BCVA between the two groups when the standard deviation of BCVA was assumed to be
0.24 logMAR and the type I error was 0.05 for two-sided test. To assess for the normal
distribution of data we used Q-Q plot and Kolmogorov-Smirnov test. To describe data we used
mean, standard deviation, median and range. To compare the results between two groups we
used t-test, Mann-Whitney, Fisher exact and Chi-Square tests. All statistical methods were
performed using SPSS software (IBM Corp. Released 2013. IBM SPSS Statistics for Windows,
Version 22.0. Armonk, NY: IBM Corp.). P-values less than 0.05 were considered statistically
significant.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04630509 -
Epidemiology and Outcome of Pediatric Traumatic Cataract
|
||
| Recruiting |
NCT03063216 -
Shanghai Pediatric Cataract Study
|