Recruiting

FLACS with IOL

Sponsor:

Sight Medical Doctors PLLC

Code:

NCT04863742

Conditions

Dry Eye Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dextenza 0.4Mg Ophthalmic Insert

Prednisolone Acetate

Study Details

Brief summary:

This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%.

Conditions

Dry Eye Syndromes

Study ID

NCT04863742

Start date

Apr 26, 2021

Status verified date

Apr, 2021

Completion date

Sep 30, 2021

Anticipated

Primary completion date

Jul 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Demonstrate objective signs of Boderline/ Mild Ocular Surface Disease (OSD) \[defined as mild symptoms, mild conjunctival staining (<2+ Superficial Punctate Keratitis), Tear Break-up Time <12s\] or demonstrate symptoms of OSD determined by SPEED questionnaire (SPEED Score <10).
2. Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes.
3. Ability to provide informed consent for procedures
4. Ability to attend scheduled follow up visits
5. No other corneal pathology to create unknown variability

Exclusion Criteria:

1. Age less than 18
2. Pregnancy/currently breast-feeding
3. Inability to provide informed consent
4. Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
5. Punctal stenosis
6. Previous corneal transplant surgery or refractive surgery
7. Concurrent use of topical steroid eye drops
8. Systemic, topical or intravitreal steroid use within 1 month of baseline
9. Active history of chronic or recurrent inflammatory eye disease in either eye
10. History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
11. History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
12. Diagnosis of Glaucoma or use of topical glaucoma drops
13. Participation in other studies in the last 6 months

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dextenza Arm

active comparator: Prednisolone Acetate 1%

Interventions

Dextenza 0.4Mg Ophthalmic Insert

sustained released dexamethasone, 0.4mg

Prednisolone Acetate

Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.

Primary outcome measure

  • Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Post-Operative Day 7 and Day 30 ]
  • Mean change in uncorrected Visual Acuity (VA) [ Time Frame: Baseline, Post-Operative Day 7 and Day 30 ]
  • Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score [ Time Frame: Baseline, Post-Operative Day 7 and Day 30 ]

Central Contacts and Locations

Central contacts

Marshel Singleton, MSN, FNP

6312314455msingleton@sightmd.com

Locations

SightMD, LIASC

Recruiting

Brentwood, New York, United States, 11717

Contacts

Marshel Singleton, MSN, FNP

6312314455msingleton@sightmd.com

More Information

Sponsor

Sight Medical Doctors PLLC

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sight Medical Doctors PLLC on 2021-04-28.