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OpenTrials
Completed

NCT Number: NCT04447157

The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia

By comparing the preoperative data and postoperative data of 9 patients of microspherophakia, we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL implantation in the surgical treatment of microspherophakia.

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Key information

Conditions

Microspherophakia

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Microspherophakia was diagnosed and lens diameter<9mm;
  • The lens subluxation was beyond the range of one quadrant and glasses cannot correct the vision;
  • Lens dislocated into the anterior chamber;
  • Lens dislocation caused elevated intraocular pressure (IOP);
  • The lens contacted the corneal endothelium;
  • Cataract;
  • Corneal endothelial cell density>1000/mm2;
  • The fundus was normal without retinal detachment, severe macular disease and optic nerve atrophy；
  • There was possible improvement in postoperative visual acuity measured by retinometer.

Exclusion criteria

  • The lens is centered and the position of the lens is stable;
  • Glasses can correct the vision obviously;
  • The reason for the elevated IOP was independent with the lens;
  • A high possibility of corneal decompensation after surgery;
  • Fundus function was poor and it is not expected to improve the vision after surgery;
  • Combined with other ocular diseases which were not suitable for IOL implantation;
  • Combined with a systemic disease that the patient cannot tolerate the surgery.

Treatment and study plan

Primary outcomes

  1. Visual function

    Time frame: 6 month postoperation

    Best corrected visual acuity (BCVA) measured using a decimal chart

  2. Visual function

    Time frame: 6 month postoperation

    uncorrected distance visual acuity (UDVA) measured using a decimal chart

  3. Intraocular pressure

    Time frame: 6 month postoperation

    intraocular pressure measured using non-contact tonometer

  4. PCIOL tilt degree

    Time frame: 6 month postoperation

    PCIOL tilt degree measured using Ultrasound biomicroscope

  5. PCIOL decentration distance

    Time frame: 6 month postoperation

    PCIOL decentration distance measured using Ultrasound biomicroscope

  6. Endothelial cell density

    Time frame: 6 month postoperation

    Endothelial cell density was measured by specular microscopy

  7. Anterior chamber depth

    Time frame: 6 month postoperation

    Anterior chamber depth measured using Ultrasound biomicroscope

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Jun 30, 2020

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.