Influence of Different Tamponade Eyes on IOL-capsular Complex

Sponsor
Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05296486
Collaborator
(none)
100
Enrollment
4
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery.A combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil(SO),gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes,gas filled eyes, balanced saline solution filled eyes and normal eyes.

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity.

Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality.

Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: phacovitrectomy surgery with silicone oil tamponade
  • Procedure: phacovitrectomy surgery with gas tamponade
  • Procedure: phacovitrectomy surgery with balanced saline solution tamponade
  • Procedure: phacoemulsifacation surgery without vitrectomy
N/A

Detailed Description

Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery. Although the optimal treatment for patients with both vitreoretinal and cataract disease is still a matter of debate, a combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil(SO),gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. As a biochemically inert polymer, SO is widely used in vitreoretinal surgery and was considered to be well-tolerated and not threatening to retinal physiology. The gases in therapeutic use ([SF6], [C2F6], or [C3F8]) may be mixed with air in vitrectomy or used as 100% gas in pneumatic retinopexy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes,gas filled eyes, balanced saline solution filled eyes and normal eyes.

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity.

Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality.

Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Influence of Different Tamponade Eyes on IOL-capsular Complex After Cataract Surgery Combined With Vitrectomy
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: phacovitrectomy surgery with silicone oil tamponade

patients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50.

Procedure: phacovitrectomy surgery with silicone oil tamponade
Patients in this study will receive phacovitrectomy surgery with silicone oil tamponade.

Experimental: phacovitrectomy surgery with gas tamponade

patients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50.

Procedure: phacovitrectomy surgery with gas tamponade
Patients in this study will receive phacovitrectomy surgery with gas tamponade

Experimental: phacovitrectomy surgery with balanced saline solution tamponade

patients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50.

Procedure: phacovitrectomy surgery with balanced saline solution tamponade
Patients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade

Experimental: phacoemulsifacation surgery without vitrectomy

patients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50.

Procedure: phacoemulsifacation surgery without vitrectomy
Patients in this study will receive phacoemulsifacation surgery without vitrectomy.

Outcome Measures

Primary Outcome Measures

  1. The position of IOL [The 1st day after surgery]

    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)

  2. The position of IOL [The 1st week after surgery]

    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)

  3. The position of IOL [The 1st month after surgery]

    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)

  4. The position of IOL [The 3rd month after surgery]

    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The patients are diagnosed age related cataract or complicated cataract with or without vitreoretinal diseases

  • The patients' age over 50 years old

  • The patients plan to receive cataract surgery with or without vitrectomy in Eye hospital of Wenzhou Medical University

  • The dilated pupils are over 7mm

  • Patients are willing and able to complete the follow-ups.

Exclusion Criteria:
  • Patients with other type of cataract

  • Patients have severe complications in the surgery and after surgery

  • Patients have other severe diseases of eyes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

  • Study Director: Yune Zhao, Ophthalmology and Optometry Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05296486
Other Study ID Numbers:
  • IOL with different tamponade
First Posted:
Mar 25, 2022
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022