An Early Phase 1 interventional study of Dextenza 0.4Mg Ophthalmic Insert and Pred Forte in Vitreoretinopathy, Coats' Disease and Exudative Retinopathy, sponsored by Lejla Vajzovic, MD, FASRS. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Lejla Vajzovic, MD, FASRS · Early Phase 1, Interventional, and Treatment
The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.
The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/laser to receive either:
Each treatment group (surgery or laser) will include 15 patients total, 10 receiving Dextenza and 5 receiving the control drug. Drops for dilation and antibiotic coverage will be used as clinically indicated in all groups throughout the study period. Follow up will occur at post-op day 1, 7, 28/30 and 45 ( +/- three days for all post-operative timepoints).
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 15 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →This is the only study on the registry with Lejla Vajzovic, MD, FASRS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions. These conditions and procedures include but are not limited to:
Conditions:
Procedures
Exclusion Criteria:
Preprocedural
Intraoperatively
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
Drug: Dextenza 0.4Mg Ophthalmic Insert
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.
Drug: Pred Forte
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
To treat perioperative ocular inflammation and pain;
Pain as Measured by the FLACC Pain Scale
The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.
Time frame: Baseline, post-op days 1, 7, 28, and 45
Number of Participants With Adverse Events
Adverse events are addressed/ assessed at each visit
Time frame: Up to post-op day 45
Severity of Adverse Events
Adverse events are addressed/ assessed at each visit
Time frame: Up to post-op day 45
Ocular Inflammation (AC Cell Count)
Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale, which ranges from 0 to 4. A higher score indicates greater inflammation.
Time frame: Baseline, post-op days 1, 7, 28, and 45
Percentage of Participants With AC (Anterior Chamber) Cell
AC (Anterior Chamber) cell is evaluated during slit lamp and fundus exams during each post-op visit. Resolution defined as AC cell measured at 0 or 0.5 (trace) after surgery.
Time frame: Post-op days 1, 7, 28, and 45
Number of Participants With Resolution of Pain
This will be measured by using the FLACC Pain Rating Scale. The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale comprised of five behavioral indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10, where a higher score indicates greater pain. Resolution of pain is defined as having a nonzero FLACC score at a postoperative visit and a FLACC score of 0 at a following visit.
Time frame: up to 45 days post-op
Change in Absolute Intraocular Pressure (IOP)
Intraocular pressure is assessed at each visit.
Time frame: Post-op days 1, 7, 28, and 45
Number of Participants With Rebound Inflammation
Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams. Rebound inflammation is defined as recurrent AC (Anterior Chamber) cell \> 0 or .5 (trace) after initial resolution.
Time frame: up to 45 days post-op
Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops
Supplemental drops needed will be documented at each subsequent visit.
Time frame: up to 45 days post-op
Number of Supplemental Drops Needed in Treatment Participants
Supplemental drops needed will be documented at each subsequent visit.
Time frame: up to 45 days post-op
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Determined by using either ETDRS (Early Treatment Diabetic Retinopathy Study) or HOTV chart (uses the letters H, O, T, and V) testing depending on age. Visual Acuities were converted to logMAR scores for statistical analyses.
Time frame: baseline, post-op days 1, 7, 28, and 45
Caregivers Treatment Adherence
Documented with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family. Reported on a Likert scale of 1 to 5, with 1 being strongly disagree and 5 being strongly agree to "I sometimes forget to administer my child's eye drops".
Time frame: Day 45 post-op
| Milestone | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Started | 11 | 4 |
| Completed | 9 | 4 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.
| score on a scale | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Baseline | 0 ± 1.42 | 0 ± 0 |
| Post-op day 1 | 0 ± 1.19 | 0 ± 0 |
| Post-op day 7 | 0 ± 0.60 | 0 ± 0 |
| Post-op day 28 | 0 ± 0 | 0 ± 0 |
| Post-op day 45 | 0 ± 0 | 0 ± 0 |
Adverse events are addressed/ assessed at each visit
| Participants | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Number of Participants With Adverse Events | 0 | 0 |
Adverse events are addressed/ assessed at each visit
No measurements were reported for this outcome.
Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale, which ranges from 0 to 4. A higher score indicates greater inflammation.
| score on a scale | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Baseline | 0 ± 0.302 | 0 ± 0 |
| Post-op day 1 | 0.5 ± 0.778 | 0 ± 0 |
| Post-op day 7 | 0.5 ± 0.592 | 0 ± 0 |
| Post-op day 28 | 0 ± 0.158 | 0 ± 0 |
| Post-op day 45 | 0 ± 0.167 | 0 ± 0 |
AC (Anterior Chamber) cell is evaluated during slit lamp and fundus exams during each post-op visit. Resolution defined as AC cell measured at 0 or 0.5 (trace) after surgery.
| percentage of participants | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Post-op day 1 | 60 | 100 |
| Post-op day 7 | 82 | 100 |
| Post-op day 28 | 100 | 100 |
| Post-op day 45 | 100 | 100 |
This will be measured by using the FLACC Pain Rating Scale. The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale comprised of five behavioral indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10, where a higher score indicates greater pain. Resolution of pain is defined as having a nonzero FLACC score at a postoperative visit and a FLACC score of 0 at a following visit.
| Participants | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Number of Participants With Resolution of Pain | 5 | — |
Intraocular pressure is assessed at each visit.
| mmHg | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Post-op day 1 | 0.0 (-4.5 to 5.5) | -5.0 (-5.5 to -3.5) |
| Post-op day 7 | 3.0 (-1.5 to 6.0) | -2.5 (-3.5 to 0.8) |
| Post-op day 28 | 2.0 (-2.5 to 4.0) | 4.5 (-0.3 to 8.0) |
| Post-op day 45 | -1.0 (-4.0 to 3.0) | 2.0 (-2.5 to 3.5) |
Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams. Rebound inflammation is defined as recurrent AC (Anterior Chamber) cell \> 0 or .5 (trace) after initial resolution.
| Participants | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Number of Participants With Rebound Inflammation | 0 | 0 |
Supplemental drops needed will be documented at each subsequent visit.
| Participants | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops | 0 | 0 |
Supplemental drops needed will be documented at each subsequent visit.
No measurements were reported for this outcome.
Determined by using either ETDRS (Early Treatment Diabetic Retinopathy Study) or HOTV chart (uses the letters H, O, T, and V) testing depending on age. Visual Acuities were converted to logMAR scores for statistical analyses.
| logMAR | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Baseline to post-op day 1 | 0.34 (0.20 to 0.76) | 1.36 (1.28 to 1.53) |
| Baseline to post-op day 7 | -0.08 (-0.285 to 0.2) | 0.375 (0.33 to 0.57) |
| Baseline to post-op day 28 | -0.25 (-0.665 to 0.06) | 0 (-0.07 to 0.14) |
| Baseline to post-op day 45 | -0.50 (-1.12 to -0.1) | -0.09 (-0.08 to -0.04) |
Documented with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family. Reported on a Likert scale of 1 to 5, with 1 being strongly disagree and 5 being strongly agree to "I sometimes forget to administer my child's eye drops".
| score on a scale | Dextenza Arm | Control Arm (Steroid Drops) |
|---|---|---|
| Caregivers Treatment Adherence | 2.00 ± 1.51 | 1.50 ± 1.89 |
Collected over Up to 45 days post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dextenza Arm | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Control Arm (Steroid Drops) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Dextenza Arm | Control Arm (Steroid Drops) | Total |
|---|---|---|---|
| Mean | 9.27 ± 2.37 | 12.25 ± 2.36 | 10.06 ± 2.37 |
| Sex: Female, Male(Participants) | Dextenza Arm | Control Arm (Steroid Drops) | Total |
|---|---|---|---|
| Female | 7 | 2 | 9 |
| Male | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Dextenza Arm | Control Arm (Steroid Drops) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 8 | 3 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Dextenza Arm | Control Arm (Steroid Drops) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 10 | 4 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Dextenza Arm | Control Arm (Steroid Drops) | Total |
|---|---|---|---|
| United States | 11 | 4 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Dexamethasone