Effectiveness Evaluation of CTR for Cataract Surgeries for Patients with Anterior Hyaloid Membrane Detachment.

JRCT ID: jRCTs042200017

Registered date:08/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Anterior Hyaloid Membrane Detachment
• Date of first enrollment: 24/08/2020
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Insertion of Capsular Tension Ring into the lens capsule.

Outcome(s)

• Primary Outcome: Decentration and tilt of Intraocular lens

Secondary Outcome

-Presence/absence of posterior capsular folds made from the aspiration-point obstruction
-Changes in anterior capsular contraction
-Changes in anterior chamber depth
-Uncorrected/Corrected distance visual acuity
-Subjective/Objective refraction
-Adverse events, device deficiencies

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1)Patients who are able to fully understand about the participation in the study and then give a written consent voluntarily and by themselves.
2)Patients who are scheduled for a lens extraction by phacoemulsification
3)Patients whose age is between 65 and 90 years at the time when giving his/her consent.
4)Patients who require a lens power from +6.00 D to 30.0 D in the study eye
5)Patients with expected postoperative CDVA of 0.5 in decimal or higher
6)Patients who are able to cooperate with postoperative follow-up visits
7)Patients with confirmed AHM detachment

Exclude criteria

1)Retinal detachment
2)A medical history of vitreous surgery
3)Diabetic retinopathy
4)Macular degeneration
5)Rubeosis iridis
6)Atopic cataract
7)Pseudoexfoliation syndrome
8)Single eye status
9)The density of cornea endothelial cell of 500cells/mm2 or less
10)Glaucoma
11)Active uveitis
12)Any abnormality in corneal epithelium, stroma or endothelium that might influence the visual acuity
13)Scheduled for other intraocular surgery besides the cataract surgery during the study period
14)Strabismus, amblyopia, or congenital ocular abnormalities
15)Psychiatric disorders or any impairment in cognitive functions
16)Judged to be ineligible by investigators for any other reasons such as a general or ophthalmic disease.
17)Anterior capsule incision (continuous curvilinear capsulorrhexis) was performed imperfectly.
18)The capsule was damaged during the surgery.
19)Serious adverse events, such as vitreous prolapse, occurred during the surgery.
20)The investigator judged him/her to be ineligible.

Related Information

• Primary Sponsor: Shibata Teppei
• Source(s) of Monetary Support: HOYA Corporation