Clinical trial NCT05480839: Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: MCS vs ReLACS
Pain Perception Postoperative
Early Anesthesia vs Standard Anesthesia
Immediately Sequential Bilateral Cataract Surgery
Lead sponsor: Uptown Eye Specialists
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
timeFrame: 1 year
Secondary outcomes:
measure: Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception
timeFrame: 1 Year
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Uptown Eye Specialist
state: Ontario
Study officials:
References: