Trial Outcomes & Findings for Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema (NCT NCT01546402)
NCT ID: NCT01546402
Last Updated: 2014-06-18
Results Overview
The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline and 6 MONTHS
Results posted on
2014-06-18
Participant Flow
Participant milestones
| Measure |
Phacoemulsification With IOL Implant
This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
|
Phacoemulsification With Ozurdex
This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Phacoemulsification With IOL Implant
n=10 Participants
This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
|
Phacoemulsification With Ozurdex
n=10 Participants
This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.56 years
STANDARD_DEVIATION 6.78 • n=5 Participants
|
59.56 years
STANDARD_DEVIATION 4.64 • n=7 Participants
|
58.56 years
STANDARD_DEVIATION 5.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 MONTHSThe primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.
Outcome measures
| Measure |
Phacoemulsification With IOL Implant
n=10 Participants
This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
|
Phacoemulsification With Ozurdex
n=10 Participants
This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
|
|---|---|---|
|
Change in the Central Macular Thickness
|
85.67 Microns
Standard Deviation 101.89
|
-18.22 Microns
Standard Deviation 76.20
|
SECONDARY outcome
Timeframe: Difference in number of letters read (6 months minus baseline)Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best
Outcome measures
| Measure |
Phacoemulsification With IOL Implant
n=10 Participants
This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
|
Phacoemulsification With Ozurdex
n=10 Participants
This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
|
|---|---|---|
|
Change in the Visual Acuity
|
0.11 Number of letters on ETDRS scale
Standard Deviation 0.05
|
15.22 Number of letters on ETDRS scale
Standard Deviation 0.023
|
Adverse Events
Phacoemulsification With IOL Implant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phacoemulsification With Ozurdex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aniruddha Agarwal
Post Graduate Institute of Medical Education and Research
Phone: +911722756111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place