Early Anesthesia vs Standard Anesthesia Clinical Trial
Official title:
A Comparison of Patient Perceptions Undergoing Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
| Verified date | July 2022 |
| Source | Uptown Eye Specialists |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The focus of this study is to assess the differences in patient perceptions of pain undergoing cataract surgery by using the Refractive Laser-Assisted Cataract Surgery (ReLACS) technique compared to the standard Manual Cataract Surgery (MCS) technique using an immediately sequential bilateral approach. This study also aims to further explore difference in patients' perceptions of pain depending on timing of neurolept anesthesia in the ReLACS technique. The importance of this study is appreciated patient perception of pain during ReLACS, which is an emerging technique for cataract surgery and has been sparsely reported on to date. This investigation will include the analysis of various surgical, ocular, medical, and psychosocial metrics of patients undergoing both ReLACS and MCS at Uptown Eye specialist.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | August 31, 2022 |
| Est. primary completion date | August 31, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patients undergoing uncomplicated cataract surgery with either surgical technique (M-ISBCS or ReLA-ISBCS) - Patients who require surgery in both eyes by the same surgeon - Able to understand English and complete a pain assessment (NRS) Exclusion Criteria: - Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery - Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy) - Pre-existing uncontrolled glaucoma/high IOP - Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery) - Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan - Patients under 40, severe obesity (BMI >35) - Chronic pain/narcotics/recreational or medical marijuana |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Uptown Eye Specialist | Brampton | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Uptown Eye Specialists |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS) | Pain perceptions of patients undergoing M-IBCS vs ReLA-ISBCS will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10. | 1 year | |
| Secondary | Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception | Pain perceptions of patients undergoing ReLA-ISBCS Early vs ReLA-ISBCS Standard will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10. | 1 Year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04623229 -
A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surgery (ReLACS) in First and Second Eyes
|
N/A |