AzTrials
AzTrials

Traumatic CataractNCT02900365

Early Vs Late Post Traumatic Cataract Surgery

A study testing early cataract surgery & IOL implantation and late cataract surgery & IOL implantation in people with Traumatic Cataract, run by Farabi Eye Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Traumatic Cataract
What is being tested?
early cataract surgery & IOL implantation and late cataract surgery & IOL implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Mar 2014to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eyes which presented with cataract and underwent surgery within 1 week were included in the early procedure group.
  • Eyes which presented with cataract and underwent surgery at least 1 month after trauma were included in the secondary procedure group.

Who cannot join

  • Eyes that primary repair and cataract extraction were done at the same time excluded from the study (because these eyes had anterior capsular rupture and disseminated lens material in the anterior chamber necessitating early surgery).
  • Also cases that IOL implantation was not possible at the time of cataract extraction were excluded.

About this study

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.

Read the detailed description

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.

Being tested
early cataract surgery & IOL implantation, late cataract surgery & IOL implantation
Keywords
trauma, cataract, lensectomy, time, early, late
Medical subject headings
Wounds and Injuries, Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • early cataract surgery & IOL implantationProcedure or surgery

    first week cataract extraction and IOL implantation.

  • late cataract surgery & IOL implantationProcedure or surgery

    first month cataract extraction and IOL implantation.

Study groups in NCT02900365
Study groupRoleWhat they receive
Early cataract surgery groupExperimentalEyes which presented with cataract and underwent surgery within 1 week were included in the early procedure group. They underwent "early cataract surgery \& IOL implantation"
Receives: Procedure: early cataract surgery & IOL implantation
Late cataract surgery groupExperimentalEyes which presented with cataract and underwent surgery at least 1 month after trauma were included in the secondary procedure group.They underwent "Late cataract surgery \& IOL implantation".
Receives: Procedure: late cataract surgery & IOL implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BCVA

    best corrected visual acuity

    Measured: 6 months

Secondary outcomes (2)
  1. Posterior capsular rupture

    Posterior capsular rupture during operation

    Measured: during operation

  2. inflammation

    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

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02900365
Sponsor's protocol ID
17865
Status last verified
Sep 2016
First submitted
27 Mar 2016
Last updated
14 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing early cataract surgery & IOL implantation and late cataract surgery & IOL implantation in people with Traumatic Cataract, run by Farabi Eye Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BCVA (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in