Xi'an First Hospital
Xi'an, Shaanxi, 710002, China
NCT Number: NCT07807436
This study compared a modified soft contact lens with balanced salt solution irrigation during pars plana vitrectomy performed with a noncontact wide-angle viewing system. Participants requiring vitrectomy were randomly assigned to have the modified lens placed on the cornea throughout surgery or to receive intermittent balanced salt solution irrigation. The study evaluated whether the modified lens could maintain a clear surgical view and protect the corneal surface. Participants were followed for one month after surgery.
Looking for future studies?
Notify MeAll sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710002, China
This prospective, randomized, parallel-group study enrolled patients with retinal diseases requiring pars plana vitrectomy at Xi'an First Hospital. All operations were performed by the same experienced vitreoretinal surgeon using a standard three-port procedure and the RESIGHT noncontact wide-angle viewing system. In the modified soft contact lens group, a silicone hydrogel corneal bandage lens modified to a diameter of 10.5 mm was placed after surgical draping and maintained throughout the operation. In the comparator group, balanced salt solution was applied intermittently to maintain corneal hydration and clarity.
Intraoperative assessments included total operative time, vitrectomy duration, frequency of corneal irrigation, and graded clarity of the surgical field. Corneal epithelial edema, fluorescein staining, tear film breakup time, and central corneal thickness were assessed before surgery and at 1 day, 1 week, and 1 month after surgery. Ocular surface symptoms were assessed using the Ocular Surface Disease Index before surgery and at 1 month.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 10.5-mm silicone hydrogel corneal bandage soft contact lens was placed on the corneal surface immediately after surgical draping and maintained throughout pars plana vitrectomy.
Balanced salt solution was applied intermittently to the corneal surface as required during pars plana vitrectomy to maintain corneal hydration and surgical-field clarity.
Time frame: During pars plana vitrectomy
Surgical-field clarity was graded on a 4-point ordinal scale: 1, poor visibility requiring corneal epithelial scraping; 2, slightly unclear but permitting basic identification of retinal vessels and the optic disc; 3, clear enough for epiretinal membrane peeling; and 4, excellent visibility permitting delicate macular procedures.
Time frame: During pars plana vitrectomy
Number of balanced salt solution applications used to maintain corneal hydration and clarity during surgery.
Time frame: During surgery
Time in minutes from the start to the end of the surgical procedure.
Time frame: During surgery
Time in minutes from insertion of the first trocar to removal of the last trocar.
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Corneal edema assessed by slit-lamp microscopy on a 5-point ordinal scale from grade 0 (transparent cornea without edema) to grade 4 (milky edema with obscured intraocular structures).
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Each corneal quadrant was scored from 0 to 3 after fluorescein staining; quadrant scores were summed to give a total score from 0 to 12, with higher scores indicating greater epithelial injury.
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Fluorescein tear film breakup time measured in seconds from the last blink to appearance of the first dark spot on the corneal surface.
Time frame: Preoperatively and at 1 day, 1 week, and 1 month after surgery
Central corneal thickness measured in micrometers using anterior-segment optical coherence tomography.
Time frame: Preoperatively and at 1 month after surgery
The 12-item Ocular Surface Disease Index was calculated on a 0-to-100 scale, with higher scores indicating more severe ocular surface symptoms.
Northwest University First Hospital (Xi'an No.1 Hospital)
Other
Effect of a Modified Soft Contact Lens Combined With a Noncontact Wide-Angle Viewing System During Vitrectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03076697
Age Related Macular Degeneration, Cardiovascular Diseases
View Trial DetailsNCT06269666
Eye Diseases, Retinal Disease
Louisville, Kentucky, United States
View Trial DetailsNCT07651943
Eye Diseases, Retinal Disease
Chongqing, Chongqing Municipality, China
View Trial DetailsNCT06455826
Eye Diseases, Eye Diseases, Hereditary
Jacksonville, Florida, United States
View Trial Details