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.
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.
- Conditions
- Traumatic Cataract
- 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 group | Role | What they receive |
|---|---|---|
| Early cataract surgery group | Experimental | Eyes 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 group | Experimental | Eyes 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.
BCVA
best corrected visual acuity
Measured: 6 months
Secondary outcomes (2)
Posterior capsular rupture
Posterior capsular rupture during operation
Measured: during operation
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.
- First posted14 Sep 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Farabi Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad soleimani, Farabi Eye Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vs Late Post Traumatic Cataract Surgery and Intraocular Lens Implantation
- ClinicalTrials.gov ID
- NCT02900365
- Acronym / sponsor ID
- 17865
- Conditions
- Traumatic Cataract
- Keywords
- trauma, cataract, lensectomy, time, early, late
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Farabi Eye HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cataract surgery group | Experimental | Procedure: early cataract surgery & IOL implantationEyes which presented with cataract and underwent surgery within 1 week were included in the early procedure group. They underwent "early cataract surgery \& IOL implantation" |
| Late cataract surgery group | Experimental | Procedure: late cataract surgery & IOL implantationEyes 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". |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early cataract surgery & IOL implantationfirst week cataract extraction and IOL implantation. | Procedure or surgery | Early cataract surgery group |
| late cataract surgery & IOL implantationfirst month cataract extraction and IOL implantation. | Procedure or surgery | Late cataract surgery group |
Primary outcome
BCVA
Time frame: 6 months
best corrected visual acuity
2 secondary outcomes
Posterior capsular rupture
Time frame: during operation
inflammation
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.